2014 Biomedicine and biomaterials catalogue

Page 1

Woodhead Publishing

Biomedicine and Biomaterials 2014 Catalogue

www.woodheadpublishing.com www.woodheadpublishingonline.com


Woodhead Publishing Online The intelligent information resource in new science and technology A major electronic resource, Woodhead Publishing Online is the only place our full collection of Biomedicine titles is available. The site offers extensive features and functionality including no DRM, no limit to the number of concurrent users and a range of innovative purchase options. E-versions of our books can be purchased as part of one of our extensive collections, as part of a Pick ‘N’ Mix selection or by individual chapter on a pay-per-view or rental basis.

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Contents Biomedicine Bioengineering, biotechnology

2

Bioinformatics, computing and life sciences

3

Genetics and genomics

5

Intellectual property, regulation

6

Life science, molecular and cellular biology

7

Management and business

10

Manufacturing and processing

13

Medical science and technology, cancer research

14

Nanoscience and technology in medicine

16

Pharmaceutical science/technology, drug delivery

17

Regenerative medicine

22

Stem cell sciences

22

Biomaterials Applications

22

Clinical techniques

28

Materials

29

Medical textiles

33

Technologies and performance

34

Title index

41

Author index

43

Order form

44

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Our books are designed to be at the leading edge of research with up-to-the-minute information on advances crucial to the future of major industries. They all contain expert knowledge and invaluable research findings from an international contributor base.

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Bioengineering, biotechnology BIOENGINEERING, BIOTECHNOLOGY NEW An introduction to biotechnology The science, technology and medical applications W T Godbey, Tulane University, USA Woodhead Publishing Series in Biomedicine No. 24

An introduction to biotechnology is a biotechnology textbook aimed at undergraduates. It covers the basics of cell biology, biochemistry and molecular biology, and introduces laboratory techniques specific to the technologies addressed in the book. It addresses specific biotechnologies at both the theoretical and application levels. CONTENTS

Part 1 The cell: Plasma membrane - phospholipids, proteins, cholesterol: Prokaryotic outer barriers - cell wall (NAMs, NAGs, crosslinking); The cytoplasm - more proteins: Enzymes (enzymes are catalysts, enzymes depend on proper protein folding, enzymes used in science, enzymes used in industry); The nucleus - organization of the genome (chromosomes, DNA fibers, nucleosomes, DNA strands, RNA); Prokaryotic genome organization - circular genome, attached to inner plasma membrane; The central dogma - transcription (Mrna); The life of a cell - the cell cycle (synthesis (S) phase, mitosis (M), gap phases, cell cycle control). Part 2 Biotechnology: Applications to and of the cell; Genetic engineering - genes (exons, introns, promoters, enhancers); Gene delivery models - viral (adenovirus, adeno-associated virus, herpesvirus, lentivirus/retrovirus); Gene delivery cargo - DNA, RNA, siRNA; Fluorescence - quantum yield, Stokes’ shift, brightness; Recombinant Proteins; Biofuels - from cellulose degradation (biochemistry of cellulose); Stem cells - cells with potential (totipotent, pluripotent, multipotent); Transgenics; Cloning.

500 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 28 2 E-ISBN: 978 1 908818 48 5 Approx. £49.50/US$80.00/€60.00 www.woodheadpublishing.com/9781907568282

NEW Electroporation-based therapies for cancer From basics to clinical applications Edited by R Sundararajan, Purdue University, USA Woodhead Publishing Series in Biomedicine No. 49

Electroporation-based therapies for cancer provides a comprehensive overview of electroporation-based clinical studies in the hospitals for various cancer treatments, including melanomas, head and neck cancers, chest wall breast carcinomas and colorectal cancers, and also looks at research studies in the lab using cell lines, primary cells, and animals. CONTENTS

Clinical electro-chemo-therapy for advanced superficial melanoma; Effective electro-chemo-therapy for chest wall recurrence of breast carcinoma; Electrochemotherapy - aspects of clinical experience; Low and high voltage electro-chemo-therapy for breast cancer: An in vitro model study; Electrically-enhanced proliferation control of cancerstem-cell-like adult human mesenchymal stem cells a novel modality of treatment; Why electroporation is a useful technique for cancer treatments; Electro-endocrine therapy for breast cancer; Electroporation of cervical and leukemia cancer cells; Targeted delivery of siRNA and other difficult to transfect molecules using electroporation; Nanosecond, low voltage pulses for electro-endocrine therapy; Low and high voltage electroporation of ovarian cancer cells; Irreversible electroporation; Electric field distribution study of malignant tumors.

250 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 15 2 E-ISBN: 978 1 908818 29 4 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568152

MATLAB® in bioscience and biotechnology L Burstein, Technion, Haifa University, Israel Woodhead Publishing Series in Biomedicine No. 3

MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems.

NEW From plant genomics to plant biotechnology Edited by S P Poltronieri, Italian National Research Council, Italy, N Burbulis, Aleksandr Stulginskis University, Lithuania and C Fogher, Catholic University, Italy Woodhead Publishing Series in Biomedicine No. 53

From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory (RNAs, DNA methylation, histone modifications and polycomb complexes), the roles of noncoding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims (biofuels, production of high-value pharmaceutical proteins in plants, abiotic stress resistant wood trees and ornamental plants). In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications. CONTENTS

From plant genomics to -omics technologies; Plant microRNAs; Epigenetic control by plant Polycomb proteins: New perspectives and emerging roles in stress response; Metabolite profiling for plant research; The uniqueness of conifers; Cryptochrome genes modulate global transcriptome of tomato; Genomics of grapevine: From genomics research on model plants to crops and from science to grapevine breeding; Grapevine genomics and phenotypic diversity of bud sports, varieties and wild relatives; Peach ripening transcriptomics unveils new and unexpected targets for the improvement of drupe quality; Application of doubled haploid technology in breeding of Brassica napus; Plant biodiversity and biotechnology; Natural resveratrol bioproduction.

274 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 29 9 E-ISBN: 978 1 908818 47 8 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568299

CONTENTS

MATLAB® basics; MATLAB® graphics; Script, function files and some useful MATLAB® functions; Ordinary and partial differential equation solvers; Bioinformatics tool for sequence analysis.

248 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 04 6 E-ISBN: 978 1 908818 03 4 £87.50/US$145.00/€105.00 www.woodheadpublishing.com/9781907568046

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Bioinformatics, computing and life sciences A biotech manager’s handbook A practical guide Edited by M O’Neill, Eolas Biosciences Limited and M M Hopkins, University of Sussex, UK Woodhead Publishing Series in Biomedicine No. 9

A biotech manager’s handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. CONTENTS

The bioscience sector: Challenges and opportunities; Academic innovation: So you want to be a bio-entrepreneur? Leadership and you; Managing self, situations and stress; It’s all in the plan; Exploring funding routes for therapeutics firms; Raising funds and managing finances; Introduction to intellectual property; Managing projects and portfolios in R&D: Why and how; Successful registration of new therapies; Clinical trials: Design and practice; Business development: Starting out; Business development: To the deal and beyond; Conclusions and final thoughts.

414 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 14 5 E-ISBN: 978 1 908818 15 7 £112.50/US$185.00/€135.00 www.woodheadpublishing.com/9781907568145

BIOINFORMATICS, COMPUTING AND LIFE SCIENCES NEW Bioinformatics for biomedical science and clinical applications K-H Liang, LinKo Medical Center, Chang Gung Memorial Hospital, Taiwan R.O.C. Woodhead Publishing Series in Biomedicine No. 20

Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions. CONTENTS

Genomics; Transcriptomics; Proteomics; Systems biomedical science; Clinical developments.

170 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 44 2 E-ISBN: 978 1 908818 23 2 £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568442

NEW Deterministic versus stochastic modelling in biochemistry and systems biology P Lecca, The Microsoft Research – University of Trento, COSBI, Italy, I Laurenzi, ExxonMobil, USA and F Jordan, The Microsoft Research – University of Trento, COSBI, Italy Woodhead Publishing Series in Biomedicine No. 21

NEW Computer-aided applications in pharmaceutical technology Edited by J Djuris, University of Belgrade, Serbia Woodhead Publishing Series in Biomedicine No. 52

Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology and chemometric methods, with emphasis on their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps) computeraided biopharmaceutical characterization, as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. CONTENTS

Quality-by-design in pharmaceutical development; Computer-aided formulation development; Experimental design application and interpretation in pharmaceutical technology; Chemometric methods application in pharmaceutical products and processes analysis and control; Neural computing in pharmaceutical products and process development; Computer-aided biopharmaceutical characterization: Gastrointestinal absorption simulation; Computational fluid dynamics: Applications in pharmaceutical technology.

300 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 27 5 E-ISBN: 978 1 908818 32 4 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568275

Deterministic versus stochastic modelling in biochemistry and systems biology introduces and critically reviews the deterministic and stochastic foundations of biochemical kinetics, covering applied stochastic process theory for application in the field of modelling and simulation of biological processes at the molecular scale. CONTENTS

Deterministic chemical kinetics; The stochastic approach to biochemical kinetics; The exact stochastic simulation algorithms; Modelling in systems biology; The structure of biochemical models; Reaction-diffusion systems; KInfer: A tool for model calibration; Modelling living systems with BlenX; Simulation of ecodynamics: Key nodes in food webs.

390 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 62 6 E-ISBN: 978 1 908818 21 8 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9781907568626

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Bioinformatics, computing and life sciences NEW Computer-aided vaccine design J C Tong, A*STAR Institute for Infocomm Research, Singapore and S Ranganathan, Macquarie University, Australia Woodhead Publishing Series in Biomedicine No. 23

Computational pre-screening of antigens is now routinely applied to the discovery of vaccine candidates. Computer-aided vaccine design is a comprehensive introduction to this exciting field of study. The book is a textbook for researchers and for courses in bioinformatics, as well as a laboratory reference guide. It is written for biologists who want to understand the current methods of computer-aided vaccine design. The contents are designed to help biologists appreciate the underlying concepts and algorithms used, as well as limitations of the methods and strategies for their use. The book is of interest to computational biologists who would like to understand more about the biological concepts related to the field of computational immunology. CONTENTS

MHC and T cell responses; Immunoglobulins and B cell responses; Scientific publications and databases; Database design; Computational T cell vaccine design; Computational B cell vaccine design; Infectious disease informatics; Vaccine safety and quality assessments; Vaccine adjuvant informatics.

164 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 41 1 E-ISBN: 978 1 908818 41 6 £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568411

Annotating new genes From in silico screening to experimental validation S Uchida, Max-Planck-Institute, Germany Woodhead Publishing Series in Biomedicine No. 15

In Annotating new genes the author considers his team’s approach as applied to evolutionary-conserved, heart-enriched genes with unknown functions. All the above mentioned methods have been validated by students working in the field of bioinformatics and developmental biology to provide a step-by-step methodology to obtain highly publishable data as well as knowledge creation that will aid the development of products which can be used in the field of regenerative medicine. CONTENTS

Open source software in life science research

Protein folding in silico Protein folding versus protein structure prediction

Practical solutions to common challenges in the pharmaceutical industry and beyond Edited by L Harland, Pfizer and M Forster, Syngenta, UK

Edited by I RotermanKonieczna, Jagiellonian University Medical College, Poland

Woodhead Publishing Series in Biomedicine No. 16

Woodhead Publishing Series in Biomedicine No. 22

The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. Examples range from core infrastructure platforms such as the apache web-server, powerful document indexing and search tools such as Lucene, through to major user-orientated systems such as Mediawiki (which powers Wikipedia) and Drupal (which powers many diverse websites). To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. CONTENTS

Building research data handling systems with open source tools; Interactive predictive toxicology with Bioclipse and OpenTox; Utilizing open source software to facilitate communication of chemistry at RSC; Open source software for mass spectrometry and metabolomics; Open source software for image processing and analysis: Picture this with ImageJ; Integrated data analysis with KNIME; InvestigationStudy-Assay, a toolkit for standardizing data capture and sharing; GenomicTools: An open source platform for developing high-throughput analytics in genomics; Creating an in-house ’omics data portal using EBI Atlas software; Setting up an ’omics platform in a small biotech; Squeezing big data into a small organisation; Design Tracker: An easy to use and flexible hypothesis tracking system to aid project team working; Free and open source software for web-based collaboration; Developing scientific business applications using open source search and visualisation technologies; Utopia Documents: Transforming how industrial scientists interact with the scientific literature; Semantic MediaWiki in applied life science and industry: Building an Enterprise Encyclopaedia; Building disease and target knowledge with Semantic MediaWiki; Chem2Bio2RDF: A semantic resource for systems chemical biology and drug discovery; TripleMap: A web-based semantic knowledge discovery and collaboration application for biomedical research; Extreme scale clinical analytics with open source software; Validation and regulatory compliance of free/open source software; The economics of free/open source software in industry.

Protein folding is a process by which a protein structure assumes its functional shape of conformation, and has been the subject of research since the publication of the first software tool for protein structure prediction. Protein folding in silico approaches this issue by introducing an ab initio model that attempts to simulate as far as possible the folding process as it takes place in vivo, and attempts to construct a mechanistic model on the basis of the predictions made. The opening chapters discuss the early stage intermediate and late stage intermediate models, followed by a discussion of structural information that affects the interpretation of the folding process. The second half of the book covers a variety of topics including ligand binding site recognition, the “fuzzy oil drop” model and its use in simulation of the polypeptide chain, and misfolded proteins. The book ends with an overview of a number of other ab initio methods for protein structure predictions and some concluding remarks. CONTENTS

The early-stage intermediate; The late-stage intermediate; Structural information involved in the interpretation of the stepwise protein folding process; The divergence entropy characterizing the internal force field in proteins; Ligandbinding-site recognition; Use of the “fuzzy oil drop” model to identify the complexation area in protein homodimers; Simulation of the polypeptide chain folding process using the “fuzzy oil drop” model; Misfolded proteins; A short description of other selected ab initio methods for protein structure prediction; Conclusion.

240 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 17 6 E-ISBN: 978 1 908818 25 6 £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568176

582 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 97 8 E-ISBN: 978 1 908818 24 9 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781907568978

Databases and software to make your research life easier; How to program like a bioinformatician? Case study: C-It, knowledge database for screening evolutionarily conserved, tissue-enriched, uncharacterized genes; Experimental validation: Concepts and practice; Further application: Adult stem cells and tissue regenerations; Conclusion.

196 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 68 8 E-ISBN: 978 1 908818 12 6 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568688

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Genetics and genomics MATLAB® in bioscience and biotechnology L Burstein, Technion, Haifa University, Israel Woodhead Publishing Series in Biomedicine No. 3

MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In the last decade Matlab has been presented to students as the first computer program they learn. Consequently, many non-programmer students, engineers and scientists have come to regard it as user-friendly and highly convenient in solving their specific problems. Numerous books are available on programming in Matlab for engineers in general, irrespective of their specialization, or for those specializing in some specific area, but none have been designed especially for such a wide, interdisciplinary, and topical area as bioengineering. Thus, in this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems - from growing populations of microorganisms and population dynamics, reaction kinetics and reagent concentrations, predator-prey models, mass-transfer and flow problems, to sequence analysis and sequence statistics. CONTENTS

MATLAB® basics; MATLAB® graphics; Script, function files and some useful MATLAB® functions; Ordinary and partial differential equation solvers; Bioinformatics tool for sequence analysis.

248 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 04 6 E-ISBN: 978 1 908818 03 4 £87.50/US$145.00/€105.00 www.woodheadpublishing.com/9781907568046

GENETICS AND GENOMICS NEW Gene expression analysis in the RNA world J Q Clement, Texas Southern University, USA Woodhead Publishing Series in Biomedicine No. 61

Gene expression analysis in the RNA world is a practical guide to the principles and techniques that are essential to RNA-based gene expression analysis. Key features include a detailed presentation of the procedures and methods for triplicates, time course, and recovery studies involving the use of multiple microarrays and correlation analysis between microarray results, RT-PCR, and Northern blotting. Each step of the microarray experimental process from bench work of RNA isolation through to computational and bioinformatics analysis is described in detail. CONTENTS

Gene expression regulation - the concept and practice of a Rnase-Free Lab; Total RNA isolation through ultracentrifugation versus commercial kits, RNA integrity assessment; Using total RNA for gene-specific expression studies using RT-PCR and Northern Analysis; Using total RNA for genome-wide expression studies using microarray analysis; Critical comments on bioinformatics software and web-based resources.

220 pages 234 x 156mm (6 x 9) hardback Q3 2015 ISBN: 978 1 907568 30 5 E-ISBN: 978 1 908818 43 0 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568305

NEW Gene therapy Potential applications of nanotechnology S Nimesh, Health Canada / Santé Canada, Canada Woodhead Publishing Series in Biomedicine No. 57

Gene therapy is emerging as a new class of therapeutics for the treatment of inherited and acquired diseases. However, poor cellular uptake and instability of DNA in the physiological milieu limits its therapeutic potential, hence a vector which can protect and efficiently transport DNA to the target cells must be developed. Nanotechnologybased non-viral vectors have been proposed as potential candidates. Various polymeric nanoparticles have been shown to be suitable, with high cellular uptake efficiencies and reduced cytotoxicity. These delivery vectors form condensed complexes with DNA which result in shielding against enzymatic degradation and enhanced cellular targeting. Advantages including easy manipulatibility, high stability, low cost and high payload, mean that nanoparticles from various polymers have been exploited. Gene therapy gives a systematic account of the many aspects of nanotechnology mediated gene therapy, from the preparation of nanoparticles to physicochemical characterization, and follows with applications in in vitro and in vivo models. This book emphasizes the various aspects of nanotechnology-based gene therapy, with initial chapters detailing the tools and techniques available for preparation and in vitro and in vivo characterization of nanoparticles. Later chapters provide exhaustive details on polymeric systems employed for gene therapy. CONTENTS

Nanotechnology: An introduction; Methods of nanoparticles preparation; Tools and techniques for physicochemical characterization of nanoparticles; In vitro and in vivo characterization of nanoparticles; Theory and limitations to gene therapy; Targeted gene delivery mediated by nanoparticles; Polymeric nanoparticles for gene delivery; Poly-L-lysine; Chitosan; Polyethylenimine; Atelocollagen; Protamine; Dendrimers; Cyclodextrin-containing polymers; PLGA based nanoparticles; Nanomaterials and metallic nanoparticles.

384 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 40 4 E-ISBN: 978 1 908818 64 5 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568404

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Intellectual property, regulation Annotating new genes From in silico screening to experimental validation S Uchida, Max-PlanckInstitute, Germany Woodhead Publishing Series in Biomedicine No. 15

In Annotating new genes the author considers his team’s approach as applied to evolutionary-conserved, heart-enriched genes with unknown functions. All the above mentioned methods have been validated by students working in the field of bioinformatics and developmental biology to provide a step-by-step methodology to obtain highly publishable data as well as knowledge creation that will aid the development of products which can be used in the field of regenerative medicine. CONTENTS

Databases and software to make your research life easier; How to program like a bioinformatician? Case study: C-It, knowledge database for screening evolutionarily conserved, tissue-enriched, uncharacterized genes; Experimental validation: Concepts and practice; Further application: Adult stem cells and tissue regenerations; Conclusion.

INTELLECTUAL PROPERTY, REGULATION NEW The impact of regulation on drug development G H Hennings, hgh regulatory sciences®, Germany Woodhead Publishing Series in Biomedicine No. 36

The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays, i.e. the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies. CONTENTS

196 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 68 8 E-ISBN: 978 1 908818 12 6 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568688

Developing effective medicines - a contribution to public health; Evolution and maintenance of global regulatory standards; Current regulatory issues of research and development pipelines; The value chain from discovery to post-authorisation research; Health authorities provide scientific (and regulatory) advice; Strategic regulatory plans and planning.

Concepts and techniques in genomics and proteomics

200 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 70 1 E-ISBN: 978 1 908818 59 1 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568701

N Saraswathy and P Ramalingam, Kumaraguru College of Technology, India Woodhead Publishing Series in Biomedicine No. 5

Concepts and techniques in genomics and proteomics covers the important concepts of high-throughput modern techniques used in the genomics and proteomics field. Each technique is explained with its underlying concepts, and simple line diagrams and flow charts are included to aid understanding and memory. A summary of key points precedes each chapter within the book, followed by detailed description in the subsections. Each subsection concludes with suggested relevant original references.

NEW Quality assurance Problem solving and training strategies for success in the pharmaceutical and life science industries G Welty, Adelphi University, USA Woodhead Publishing Series in Biomedicine No. 55

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of revised procedures. The third part expands on this discussion by considering piloting the proposed module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. CONTENTS

Part 1 A systematic approach to problem solving: Framework for continuous improvement; Investigations, root cause analyses and CAPAs; The role of critical review in the revision of procedures; Working with standard operating procedures (SOPs). Part 2 Designing and developing training materials: The design phase of the program improvement model; Content development: A new employee orientation program; Content development: A continuing cGMP training program; Content development: Qualification of employees. Part 3 Using the training materials: Assessing trainee proficiency; Pilot implementation; Training record- keeping; Formative evaluation; Final implementation.

374 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 36 7 E-ISBN: 978 1 908818 62 1 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568367

CONTENTS

Introduction to genes and genomes; The human genome project; Genomes of model organisms; High capacity vectors; DNA sequencing methods; Genome mapping; Genome sequencing methods; Genome sequence assembly and annotation; Functional genomics; Introduction to proteomics; Two-dimensional gel electrophoresis of proteins; Mass spectrometry for proteomics; Protein Identification by Peptide Mass Fingerprinting (PMF); Protein sequencing techniques; Phosphoproteomics; Glycoproteomics.

268 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 10 7 E-ISBN: 978 1 908818 05 8 £72.50/US$120.00/€85.00 www.woodheadpublishing.com/9781907568107

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Life science, molecular and cellular biology NEW Biobanks Patents or open science? A De Robbio, University of Padova, Italy Woodhead Publishing Series in Biomedicine No. 13

Biobanks represent an invaluable research tool and, as a result of their intrinsic and extrinsic nature, may be looked upon as archives or repositories largely made up of libraries, or collections of content where the content is the biological material derived from different individuals or species, representing valuable tangible assets. Biobanks analyses aspects of the commons and common intellectual property relating to the concepts of private property, not only concerning data but biological materials as well, and the advantages and disadvantages of patents in scientific research. Several recent initiatives in biomedical research have attempted to make their data freely available to others, so as to foster innovation. Many of these initiatives have adopted the open source model, which has gained widespread recognition in the computer industry. This title is structured into eight chapters and begins with an introduction, which is followed by chapters that discuss how the term ‘biobank’ came about in scientific literature; legal matters relating to biobanks; and intellectual and physical property. Later chapters comprehensively analyse the intellectual property of biobanks within the sphere of copyright; biotechnological inventions and research patentability; open data sharing in biobanks; and biobanks as commons or vault. CONTENTS

How the term “biobank” came about in scientific literature; Legal matters relating to biobanks: Privacy, confidentiality and informed consent; Intellectual and physical property; The intellectual property of biobanks within the sphere of copyright; Biotechnological inventions and research patentability; Open data sharing in biobanks: Open science and its impact on society; Biobanks: Commons or vault?

70 pages 234 x 156mm (6 x 9) paperback 2013 ISBN: 978 1 907568 34 3 E-ISBN: 978 1 908818 61 4 £85.00/US$140.00/€100.00 www.woodheadpublishing.com/9781907568343

Patently innovative How pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugs R A Bouchard, Intellectual Property Lawyer and Scholar, Canada Woodhead Publishing Series in Biomedicine No. 7

Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products. CONTENTS

Drug approval, drug patenting, pharmaceutical linkage, and public health policy; Empirical analysis of drug approval; Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage; Empirical analysis of drug patenting in multiple high-value cohorts; Implications of empirical data: Are pharmaceutical linkage regulations a success? Future directions: Testable hypotheses and evolution toward global pharmaceutical linkage.

296 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 12 1 E-ISBN: 978 1 908818 08 9 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568121

Contract research and manufacturing services (CRAMS) in India The business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectors Edited by M Antani and G Gokhale, Nishith Desai Associates, India

LIFE SCIENCE, MOLECULAR AND CELLULAR BIOLOGY NEW Fed-batch fermentation A practical guide to scalable recombinant protein production in Escherichia coli G G Moulton Woodhead Publishing Series in Biomedicine No. 42

Fed-batch fermentation is primarily a practical guide for recombinant protein production in E. coli using a fed-batch fermentation process. Ideal users of this guide are teaching labs and R&D labs that need a quick and reproducible process for recombinant protein production. It may also be used as a template for the production of recombinant protein product for use in clinical trials. The guide highlights a method whereby a medium cell density - final Ods = 30-40 (A600) - fed-batch fermentation process can be accomplished within a single day with minimal supervision. This process can also be done on a small (2L) scale that is scalable to 30L or more. All reagents (media, carbon source, plasmid vector and host cell) used are widely available and are relatively inexpensive. This method has been used to produce three different protein products following cGMP guidelines for Phase I clinical studies. CONTENTS

Introduction to fermentation; Typical recombinant E. coli host cells and plasmids used; Generation of recombinant clone and working cell bank; Generation of inoculants for fed-batch culture; Fed-batch culture method; Analysis of growth and production data; Parametric analysis for periplasmic soluble production of recombinant product.

270 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 1 907568 92 3 E-ISBN: 978 1 908818 33 1 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568923

Woodhead Publishing Series in Biomedicine No. 19

Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India. CONTENTS

Overview of CRAMS; Legal and regulatory scenario; Issues and concerns; Tax environment and related issues; Service agreements; Negotiating a contract; Outlook and conclusion.

248 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 19 0 E-ISBN: 978 1 908818 16 4 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568190

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Life science, molecular and cellular biology NEW Gene expression analysis in the RNA world J Q Clement, Texas Southern University, USA Woodhead Publishing Series in Biomedicine No. 61

Gene expression analysis in the RNA world is a practical guide to the principles and techniques that are essential to RNA-based gene expression analysis. Key features include a detailed presentation of the procedures and methods for triplicates, time course, and recovery studies involving the use of multiple microarrays and correlation analysis between microarray results, RT-PCR, and Northern blotting. Each step of the microarray experimental process from bench work of RNA isolation through to computational and bioinformatics analysis is described in detail. CONTENTS

Gene expression regulation - the concept and practice of a Rnase-Free Lab; Total RNA isolation through ultracentrifugation versus commercial kits, RNA integrity assessment; Using total RNA for gene-specific expression studies using RT-PCR and Northern Analysis; Using total RNA for genome-wide expression studies using microarray analysis; Critical comments on bioinformatics software and web-based resources.

220 pages 234 x 156mm (6 x 9) hardback Q3 2015 ISBN: 978 1 907568 30 5 E-ISBN: 978 1 908818 43 0 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568305

NEW Ultrafiltration for bioprocessing H Lutz, Millipore Corporation, USA Woodhead Publishing Series in Biomedicine No. 29

Ultrafiltration (UF) is a key process in the bioprocessing area and is used in almost every bioprocess. Ultrafiltration for bioprocessing is written by a leading worker in the area and includes many practical applications and case studies. It is key reading for all those involved in the biotechnology and biopharmaceutical areas. CONTENTS

Fundamentals; Membranes; Modules; Process configurations; Processing; Recovery; Cleanup; Manufacturing systems; Trouble shooting.

200 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 46 6 E-ISBN: 978 1 908818 53 9 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568466

NEW An introduction to biotechnology The science, technology and medical applications W T Godbey, Tulane University, USA Woodhead Publishing Series in Biomedicine No. 24

An introduction to biotechnology is a biotechnology textbook aimed at undergraduates. It covers the basics of cell biology, biochemistry and molecular biology, and introduces laboratory techniques specific to the technologies addressed in the book. It addresses specific biotechnologies at both the theoretical and application levels. CONTENTS

Part 1 The cell: Plasma membrane - phospholipids, proteins, cholesterol: Prokaryotic outer barriers - cell wall (NAMs, NAGs, crosslinking); The cytoplasm - more proteins: Enzymes (enzymes are catalysts, enzymes depend on proper protein folding, enzymes used in science, enzymes used in industry; The nucleus - organization of the genome (chromosomes, DNA fibers, nucleosomes, DNA strands, RNA); Prokaryotic genome organization - circular genome, attached to inner plasma membrane; The central dogma - transcription (Mrna); The life of a cell - the cell cycle (synthesis (S) phase, mitosis (M), gap phases, cell cycle control). Part 2 Biotechnology: Applications to and of the cell; Genetic engineering - genes (exons, introns, promoters, enhancers); Gene delivery models - viral (adenovirus, adeno-associated virus, herpesvirus, lentivirus/retrovirus); Gene delivery cargo - DNA, RNA, siRNA; Fluorescence - quantum yield, Stokes’ shift, brightness; Recombinant Proteins; Biofuels - from cellulose degradation (biochemistry of cellulose); Stem cells - cells with potential (totipotent, pluripotent, multipotent); Transgenics; Cloning.

500 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 28 2 E-ISBN: 978 1 908818 48 5 Approx. £49.50/US$80.00/€60.00 www.woodheadpublishing.com/9781907568282

NEW Marine enzymes for biocatalysis Sources, biocatalytic characteristics and bioprocesses of marine enzymes A Trincone, Istituto di Chimica Biomolecolare (I.C.B.), Italy Woodhead Publishing Series in Biomedicine No. 38

NEW From plant genomics to plant biotechnology Edited by S P Poltronieri, Italian National Research Council, Italy, N Burbulis, Aleksandr Stulginskis University, Lithuania and C Fogher, Catholic University, Italy Woodhead Publishing Series in Biomedicine No. 53

From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory (RNAs, DNA methylation, histone modifications and polycomb complexes), the roles of noncoding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims (biofuels, production of high-value pharmaceutical proteins in plants, abiotic stress resistant wood trees and ornamental plants). In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications. CONTENTS

From plant genomics to -omics technologies; Plant microRNAs; Epigenetic control by plant Polycomb proteins: New perspectives and emerging roles in stress response; Metabolite profiling for plant research; The uniqueness of conifers; Cryptochrome genes modulate global transcriptome of tomato; Genomics of grapevine: From genomics research on model plants to crops and from science to grapevine breeding; Grapevine genomics and phenotypic diversity of bud sports, varieties and wild relatives; Peach ripening transcriptomics unveils new and unexpected targets for the improvement of drupe quality; Application of doubled haploid technology in breeding of Brassica napus; Plant biodiversity and biotechnology; Natural resveratrol bioproduction.

274 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 29 9 E-ISBN: 978 1 908818 47 8 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568299

Marine enzymes for biocatalysis initially examines the nature and level of interest in marine biological diversity, and outlines the fundamentals of biocatalysis. It goes on to detail sources of marine enzymes and analyses examples from both chemical and stereochemical viewpoints of catalysis, including microbial enzymes and animal or plant sources. The book goes on to explore the future potential of marine bioprospecting in biocatalysis. CONTENTS

Source of marine enzymes; Processes and biocatalytic characteristics; Bioprocesses; Biocatalytic characteristics.

576 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 80 0 E-ISBN: 978 1 908818 35 5 £165.00/US$270.00/€200.00 www.woodheadpublishing.com/9781907568800

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Life science, molecular and cellular biology NEW Bacterial cellular metabolic systems Metabolic regulation of a cell system with 13 C-metabolic flux analysis K Shimizu, Kyushu Institute of Technology and Institute of Advanced Biosciences of Keio University, Japan Woodhead Publishing Series in Biomedicine No. 18

Bacterial cellular metabolic systems focuses on this highly topical subject in relation to culture environment and provides a detailed analysis from gene level to metabolic level regulation, as well as offering a discussion of the most recent modelling approaches. The book begins with an introduction to metabolic mechanisms and to the metabolic regulation of a cell, before moving on to discussing the action of global regulators in response to a specific culture environment. The second half of the book examines conventional flux balance analysis and its applications, 13 C-metabolic flux analysis, and the effect of a specific gene knockout on the metabolism. CONTENTS

Main metabolism; Brief overview of metabolic regulation of a bacterial cell; Metabolic regulation by global regulators in response to culture environment; Conventional flux balance analysis and its applications; 13C-metabolic flux analysis and its applications; Effect of a specific-gene knockout on metabolism.

496 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 01 5 E-ISBN: 978 1 908818 20 1 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9781907568015

Human papillomavirus infections From the laboratory to clinical practice F Cobo, Hospital de Poniente, Spain Woodhead Publishing Series in Biomedicine No. 14 ‘This succinct review of the various facets of HPV invection and disease will be very useful for the intended audiences interested in this subject.’

Doody’s Reviews Human papillomavirus (HPV) is one of the most common causes of sexually transmitted diseases worldwide, both in men and women. Human papillomavirus infections provides the scientific background needed to understand the natural history and pathogenesis of HPV infection and offers discussion of its clinical features, diagnosis, treatment and prevention. CONTENTS

Introduction and epidemiological data; Basic virology: Structure and nomenclature; Natural history and transmission: Anatomic distribution; Pathogenesis and clinical features; HPV infection and association with cancer; Diagnosis of HPV infection; Clinical utility of HPV testing; Treatment; Prevention: HPV vaccines.

168 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 74 9 E-ISBN: 978 1 908818 17 1 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568749

Therapeutic antibody engineering

Therapeutic protein drug products

Current and future advances driving the strongest growth area in the pharmaceutical industry

Practical approaches to formulation in the laboratory, manufacturing, and the clinic

W R Strohl, Johnson & Johnson Biotechnology Center of Excellence and L M Strohl, Medical Illustrator, USA

Edited by B K Meyer, Merck Research Laboratories (MRL), USA

Woodhead Publishing Series in Biomedicine No. 11 ‘An excellent balance between readability and depth of material.... The book is well referenced and provides plentiful opportunities to continue subject-specific learning.’

mAbs Journal ‘An excellent book describing many aspects of therapeutic antibody generation and the current market share of these drugs. It is an up-to-date evaluation of their production and clinical utility.’

Doody’s Reviews Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on candidates of the future. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. In the following chapters, the book covers a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. CONTENTS

Introduction to biologics and monoclonal antibodies; Value proposition for therapeutic monoclonal antibodies and Fc fusion proteins; Antibody structure–function relationships; Fundamental technologies for antibody engineering; Sources of antibody variable chains; Variable chain engineering – humanization and optimization approaches; Antibody interactions with the immune system; Monoclonal antibody targets and mechanisms of action; Therapeutic antibody classes; Antibody Fc engineering for optimal antibody performance; IgG glycans and glyco-engineering; Antibody fragments as therapeutics; Multiple antibody and multispecificity approaches; FcFPs and similar constructs using Fc; Antibody-drug conjugates; Development issues: Antibody stability, developability, immunogenicity, and comparability; Interactions of human IgGs with non-human systems; Cell line development; Issues facing therapeutic monoclonal antibodies for the future.

696 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 37 4 E-ISBN: 978 1 908818 09 6 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781907568374

Woodhead Publishing Series in Biomedicine No. 8

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. CONTENTS

Commercial therapeutic protein drug products; A formulation method to improve the physical stability of macromolecularbased drug products; Properties of protein formulations; Material and process compatibility testing; Compounding and filling: Drug substance to drug product; Administration in the clinic; Regulatory guidelines for the development of a biotechnology drug product.

200 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 18 3 E-ISBN: 978 1 908818 10 2 £112.50/US$185.00/€135.00 www.woodheadpublishing.com/9781907568183

Concepts and techniques in genomics and proteomics N Saraswathy and P Ramalingam, Kumaraguru College of Technology, India Woodhead Publishing Series in Biomedicine No. 5 CONTENTS

Introduction to genes and genomes; The human genome project; Genomes of model organisms; High capacity vectors; DNA sequencing methods; Genome mapping; Genome sequencing methods; Genome sequence assembly and annotation; Functional genomics; Introduction to proteomics; Two-dimensional gel electrophoresis of proteins; Mass spectrometry for proteomics; Protein Identification by Peptide Mass Fingerprinting (PMF); Protein sequencing techniques; Phosphoproteomics; Glycoproteomics.

268 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 10 7 E-ISBN: 978 1 908818 05 8 £72.50/US$120.00/€85.00 www.woodheadpublishing.com/9781907568107

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9


Management and business Open source software in life science research Practical solutions to common challenges in the pharmaceutical industry and beyond Edited by L Harland, Pfizer and M Forster, Syngenta, UK Woodhead Publishing Series in Biomedicine No. 16

The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. Examples range from core infrastructure platforms such as the apache web-server, powerful document indexing and search tools such as Lucene, through to major user-orientated systems such as Mediawiki (which powers Wikipedia) and Drupal (which powers many diverse websites). To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. CONTENTS

Building research data handling systems with open source tools; Interactive predictive toxicology with Bioclipse and OpenTox; Utilizing open source software to facilitate communication of chemistry at RSC; Open source software for mass spectrometry and metabolomics; Open source software for image processing and analysis: Picture this with ImageJ; Integrated data analysis with KNIME; InvestigationStudy-Assay, a toolkit for standardizing data capture and sharing; GenomicTools: An open source platform for developing high-throughput analytics in genomics; Creating an in-house ’omics data portal using EBI Atlas software; Setting up an ’omics platform in a small biotech; Squeezing big data into a small organisation; Design Tracker: An easy to use and flexible hypothesis tracking system to aid project team working; Free and open source software for web-based collaboration; Developing scientific business applications using open source search and visualisation technologies; Utopia Documents: Transforming how industrial scientists interact with the scientific literature; Semantic MediaWiki in applied life science and industry: Building an Enterprise Encyclopaedia; Building disease and target knowledge with Semantic MediaWiki; Chem2Bio2RDF: A semantic resource for systems chemical biology and drug discovery; TripleMap: A web-based semantic knowledge discovery and collaboration application for biomedical research; Extreme scale clinical analytics with open source software; Validation and regulatory compliance of free/open source software; The economics of free/open source software in industry.

MANAGEMENT AND BUSINESS NEW Successful biopharmaceutical operations Driving change C Driscoll, Driscoll Consulting Group, USA Woodhead Publishing Series in Biomedicine No. 48

Successful biopharmaceutical operations provides a practical guide to transforming biopharma companies into industry leaders through a focus on driving change. The industry has a blind spot concerning this kind of work, because successful change management comes from a focus on people, while our technically-minded ranks invariably prefer a technical focus. This cognitive bias causes us to pick up the tools we like the best and to swing them enthusiastically - whether they are working or not. This book provides new tools, and readers gain an understanding of how biopharma organizations developed into the cultures we see currently. CONTENTS

Part 1 The need for change: Something isn’t right?; The problem of smart people; The ease of fundamentalism; The silo skyline; Integrating the appearance of improvement; Call it what it is: Cost reduction; When you turn the wheel and nothing happens; When you take public opinion polls to see what’s wrong; When you realize you run a daycare center. Part 2 The change process: Change management framework; Cognitive bias; The compliance card; Simplicity vs. complexity; Accountability vs. innocent bystander; Bringing it all together: Engagement, gameplan, sustainability. Part 3 Noise (you’ll want to read this): Lessons from Oobleck; They’re under too much pressure; We need to give them time; They don’t feel comfortable bringing things up.

270 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 13 8 E-ISBN: 978 1 908818 42 3 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568138

582 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 97 8 E-ISBN: 978 1 908818 24 9 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781907568978

NEW The impact of regulation on drug development G H Hennings, hgh regulatory sciences®, Germany Woodhead Publishing Series in Biomedicine No. 36

The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays, i.e. the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies. CONTENTS

Developing effective medicines - a contribution to public health; Evolution and maintenance of global regulatory standards; Current regulatory issues of research and development pipelines; The value chain from discovery to post-authorisation research; Health authorities provide scientific (and regulatory) advice; Strategic regulatory plans and planning.

200 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 70 1 E-ISBN: 978 1 908818 59 1 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568701

NEW Therapeutic risk management of medicines S J Mayall and A K Banerjee, Pope Woodhead & Associates, UK Woodhead Publishing Series in Biomedicine No. 30

Legislation has evolved rapidly over the last decade and Therapeutic risk management of medicines is an authoritative, yet practical, guide on planning, writing, implementing and evaluating risk management plans for medicines globally. The book also includes chapters on the historical development, lessons from other industries, the regulatory and health authority perspective and public communication of benefit risk. This topic is of critical importance not only to the pharmaceutical and biotechnology industry, but also prescribers, pharmacists, regulators and healthcare policymakers. CONTENTS

Introduction and historical background of risk management plans; EU-RMP (Risk Management Plan); USA REMS (Risk Evaluation and Mitigation Strategies); Safety specification; Pharmacovigilance planning; Assessing the need for risk minimization; Risk minimization tools; Implementation of RMPs and REMS; Evaluation of RMPs and REMS; Developmental risk management plans; Effectively negotiating with the health authorities; Public communication of benefit risk.

250 pages 234 x 156mm (6 x 9) hardback 2014 ISBN: 978 1 907568 48 0 E-ISBN: 978 1 908818 27 0 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568480

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Management and business NEW CAPA in the pharmaceutical and biotech industries How to implement an effective nine step program J Rodriguez, Monarch Quality Systems Solutions, USA Woodhead Publishing Series in Biomedicine No. 33

CAPA in the pharmaceutical and biotech industries contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system. CONTENTS

Step-by-step basics on how to build a comprehensive CAPA program; How to use a nine step CAPA process to effectively handle any product or quality system failures; How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner; How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk; How to use Failure Mode and Effect Analysis to identify potential failure modes; How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities; Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions; Efficient use of root cause analysis tools; Optimizing CAPA and RCA documentation procedures; Essential SOPs and other documentation; Review areas of common FDA’s 483 inspection observations; How to effectively identify and track deviations and non-conformances; Learning to analyse and trend data to identify existing and potential causes of non-conformance; Gathering, organizing and managing the correct data required to conduct an effective Root Cause Investigation; Review the elements of a good investigation; Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling; Performing trend analysis and using effective RCA tools; How to use of statistical methodologies when performing Root Cause Analysis; CAPA and the linkage to effective management review and annual product reviews; Step-by-step basics on how to build your own comprehensive CAPA program; Most important: Review of the real benefits of an effective CAPA system.

270 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 58 9 E-ISBN: 978 1 908818 37 9 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568589

NEW The application of statistical process control in the pharmaceutical and biotechnology industries A practical approach T Cochrane, Napp Pharmaceutical Group, UK Woodhead Publishing Series in Biomedicine No. 28

The application of statistical process control in the pharmaceutical and biotechnology industries is a starting point for anyone interested in or tasked with introducing these new pharma initiatives. This book is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. It considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way. CONTENTS

History of statistical process control; Why now in the pharmaceutical and biotech industry; Getting the culture right; The pharmaceutical industry; The system; SPC theory; Raw materials and supplier development; Key parameters; Auditing; Manufacturing processes; Training; Finished product testing; Critical quality attributes; Validation; Continuous verification; The annual product review; Putting all the information together; Reducing the risk in the system; Continuous improvement teams; Sales; Case studies.

220 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 33 6 E-ISBN: 978 1 908818 36 2 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568336

NEW The funding of biopharmaceutical research and development D R Williams, Appalachian State University, USA Woodhead Publishing Series in Biomedicine No. 43

The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. CONTENTS

Introduction to the biopharmaceutical market; Synopsis of theories of the firm and valuation methods; Innovation and the merging of the pharmaceutical and biotechnology industries; The funding of basic research and public–private partnerships; Strategic alliances; Angel and venture capital; The initial public offering; Conclusion.

284 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 94 7 E-ISBN: 978 1 908818 38 6 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568947

NEW Lean biomanufacturing Creating value through innovative bioprocessing approaches N J Smart, Smart Consulting Group, USA Woodhead Publishing Series in Biomedicine No. 37

The objective of this book is to re-visit lean principles and then apply them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. CONTENTS

An introduction to lean biomanufacturing; Lean technologies/ methods to be applied to biomanufacturing; Creation, execution and implementation of the Transition Plan; Issues and problems for the biopharmaceutical industry that make the situation challenging; Developing a lean approach to biopharmaceutical processes; The contribution of simulation models in the development of lean biopharmaceutical processes; Integration of biomanufacturing with lean laboratory operations; Lean compliance and considerations connected with enabling lean manufacturing; Ready to use technologies and their role in lean biomanufacturing.

384 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 78 7 E-ISBN: 978 1 908818 40 9 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568787

NEW Orphan drugs Understanding the rare disease market and its dynamics E Hernberg-Stahl, Late Phase Solutions Europe AB, Sweden and M Reljanovic Woodhead Publishing Series in Biomedicine No. 46

There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. Orphan drugs provides a comprehensive overview of strategy, key activities and considerations of how to bring an orphan drug from concept to the market and make it available to patients. It is a source of updated information, news and trends for those who are already active in this fast-moving field. CONTENTS

Orphan drugs and orphan drug legislation; Characteristics of rare diseases; Patient network and advocacy groups; Organisations and networks dedicated to rare diseases and orphan drugs; Policies and research funding; Designing robust clinical trials for orphan drugs; Market access procedures for orphan drugs.

334 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 09 1 E-ISBN: 978 1 908818 39 3 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568091

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Management and business NEW 21st Century quality management and good management practices Value added compliance for the pharmaceutical and biotechnology industry S Williams, Consultant, Australia Woodhead Publishing Series in Biomedicine No. 31

21st Century quality management and good management practices is a practical guide on how to apply 21st century principles in the pharmaceutical and biotechnology workplace. The book includes simple understandable examples and case studies on modern compliance. The book serves as a practitioner’s guide and is an ideal companion for pharmaceutical and biotechnology industry professionals and students studying quality management and GMP compliance. CONTENTS

International rules and regulations in the life science industry; Pharmaceutical quality management and quality systems (ICH Q10); Fundamentals of good manufacturing practices (GMP); Validation; Pharmaceutical quality risk management (ICH Q9); Building quality into products (ICH Q8 and QbD); Process control and process analytical technology; CAPA, failure investigation and root cause analysis; Effective training and education; Behavioural GMPs, deviations and human error reduction; Supply chain integrity; Compliance auditing and product reviews.

250 pages 234 x 156mm (6 x 9) hardback Q2 2015 ISBN: 978 1 907568 50 3 E-ISBN: 978 1 908818 56 0 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568503

Outsourcing biopharma R&D to India P R Chowdhury, J. Sagar Associates, India Woodhead Publishing Series in Biomedicine No. 2

Several global pharma-biotech majors ascertained large market requirements within India and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. CONTENTS

Biopharma outsourcing in India: Its evolution; India’s core competitive advantage in R&D in the biopharma sector: The impetus for outsourcing; Different modes of outsourcing biopharma R&D to India; The Indian regulatory environment: A historical perspective; Implications of the changing regulatory environment in India; Creating contracts for outsourcing in the biopharma industry; Environmental, health and safety guidelines and biopharma outsourcing: An Indian perspective; Certifications; The need for due diligence of service providers.

Contract research and manufacturing services (CRAMS) in India

A practical guide Edited by M O’Neill, Eolas Biosciences Limited and M M Hopkins, University of Sussex, UK

The business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectors

Woodhead Publishing Series in Biomedicine No. 9

Edited by M Antani and G Gokhale, Nishith Desai Associates, India Woodhead Publishing Series in Biomedicine No. 19

Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. CONTENTS

Overview of CRAMS; Legal and regulatory scenario; Issues and concerns; Tax environment and related issues; Service agreements; Negotiating a contract; Outlook and conclusion.

248 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 19 0 E-ISBN: 978 1 908818 16 4 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568190

Practical leadership for biopharmaceutical executives J Y Chin, Medical Science Liaison (MSL) Institute, USA Woodhead Publishing Series in Biomedicine No. 1 CONTENTS

Leadership as a phenomenon; Seven managerial leadership competencies; Three commitments of pharmaceutical executives: Presence; Three commitments of pharmaceutical executives: Stewardship; Three commitments of pharmaceutical executives: Development; Self-concept as leader; Conclusion: A new model of biopharmaceutical executive leadership.

216 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 06 0 E-ISBN: 978 1 908818 02 7 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568060

130 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 08 4 E-ISBN: 978 1 908818 01 0 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568084

12

A biotech manager’s handbook

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A biotech manager’s handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. The book starts with outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). CONTENTS

The bioscience sector: Challenges and opportunities; Academic innovation: So you want to be a bio-entrepreneur? Leadership and you; Managing self, situations and stress; It’s all in the plan; Exploring funding routes for therapeutics firms; Raising funds and managing finances; Introduction to intellectual property; Managing projects and portfolios in R&D: Why and how; Successful registration of new therapies; Clinical trials: Design and practice; Business development: Starting out; Business development: To the deal and beyond; Conclusions and final thoughts.

414 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 14 5 E-ISBN: 978 1 908818 15 7 £112.50/US$185.00/€135.00 www.woodheadpublishing.com/9781907568145

Commercializing the stem cell sciences O Harvey, University of Sydney, Australia Woodhead Publishing Series in Biomedicine No. 12

Commercializing the stem cell sciences offers a comparative analysis of the commercial methods adopted in the global stem cell industries. It seeks to establish whether there is an optimum commercial model and to examine what emerging companies can learn from their predecessors. Following an introduction to stem cell sciences and the problems involved in their commercialization, the book begins with a discussion of stem cell treatments from a global perspective, and the role of innovation in the commercialization of biotechnology in general. In the second half of the book, chapters focus on the different strategies that can be employed and their relative risks and values, before a conclusion that looks at potential new developments in the field. CONTENTS

Introduction: Stem cell science, biotechnology and the problem of commercialization; Stem cell treatments in a global marketplace; The role of innovation systems in the commercialization of biotechnology; Low-risk, low-value: Adult stem cells; High-risk, high-value: Embryonic stem cells; Low-risk, low-value: iPS cells; What does the future hold?

212 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 60 2 E-ISBN: 978 1 908818 14 0 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568602

Available / will be available on Woodhead Publishing Online


Manufacturing and processing Patently innovative How pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugs R A Bouchard, Intellectual Property Lawyer and Scholar, Canada Woodhead Publishing Series in Biomedicine No. 7

Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products. CONTENTS

Drug approval, drug patenting, pharmaceutical linkage, and public health policy; Empirical analysis of drug approval; Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage; Empirical analysis of drug patenting in multiple high-value cohorts; Implications of empirical data: Are pharmaceutical linkage regulations a success? Future directions: Testable hypotheses and evolution toward global pharmaceutical linkage.

296 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 12 1 E-ISBN: 978 1 908818 08 9 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568121

Clinical research in Asia Opportunities and challenges

MANUFACTURING AND PROCESSING NEW Ultrafiltration for bioprocessing

Woodhead Publishing Series in Biomedicine No. 10 ‘An important contribution to the field of global research ethics’

Doody’s Book Reviews Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. CONTENTS

Clinical research in Asia: A brief overview; Clinical research in Japan; Clinical research in India; Clinical research in China; Clinical research in South Korea; Clinical research in Taiwan; Clinical research in Singapore; Clinical research in Thailand; Clinical research in Malaysia; Clinical research in Hong Kong; Clinical research in the Philippines, Indonesia and Vietnam; Conclusions.

412 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 00 8 E-ISBN: 978 1 908818 13 3 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568008

How to implement an effective nine step program

H Lutz, Millipore Corporation, USA

J Rodriguez, Monarch Quality Systems Solutions, USA

Woodhead Publishing Series in Biomedicine No. 29

Woodhead Publishing Series in Biomedicine No. 33

Ultrafiltration (UF) is a key process in the bioprocessing area and is used in almost every bioprocess. Ultrafiltration for bioprocessing is written by a leading worker in the area and includes many practical applications and case studies. It is key reading for all those involved in the biotechnology and biopharmaceutical areas.

CAPA in the pharmaceutical and biotech industries contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system.

CONTENTS

Fundamentals; Membranes; Modules; Process configurations; Processing; Recovery; Cleanup; Manufacturing systems; Trouble shooting.

200 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 46 6 E-ISBN: 978 1 908818 53 9 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568466

NEW The application of statistical process control in the pharmaceutical and biotechnology industries A practical approach T Cochrane, Napp Pharmaceutical Group, UK Woodhead Publishing Series in Biomedicine No. 28

U Sahoo, Chiltern, India

NEW CAPA in the pharmaceutical and biotech industries

The application of statistical process control in the pharmaceutical and biotechnology industries is a starting point for anyone interested in or tasked with introducing these new pharma initiatives. This book is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. It considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way.

CONTENTS

Step-by-step basics on how to build a comprehensive CAPA program; How to use a nine step CAPA process to effectively handle any product or quality system failures; How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner; How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk; How to use Failure Mode and Effect Analysis to identify potential failure modes; How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities; Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions; Efficient use of root cause analysis tools; Optimizing CAPA and RCA documentation procedures; Essential SOPs and other documentation; Review areas of common FDA’s 483 inspection observations; How to effectively identify and track deviations and non-conformances; Learning to analyse and trend data to identify existing and potential causes of non-conformance; Gathering, organizing and managing the correct data required to conduct an effective Root Cause Investigation; Review the elements of a good investigation; Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling; Performing trend analysis and using effective RCA tools; How to use of statistical methodologies when performing Root Cause Analysis; CAPA and the linkage to effective management review and annual product reviews; Step-by-step basics on how to build your own comprehensive CAPA program; Most important: Review of the real benefits of an effective CAPA system.

270 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 58 9 E-ISBN: 978 1 908818 37 9 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568589

CONTENTS

History of statistical process control; Why now in the pharmaceutical and biotech industry; Getting the culture right; The pharmaceutical industry; The system; SPC theory; Raw materials and supplier development; Key parameters; Auditing; Manufacturing processes; Training; Finished product testing; Critical quality attributes; Validation; Continuous verification; The annual product review; Putting all the information together; Reducing the risk in the system; Continuous improvement teams; Sales; Case studies.

220 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 33 6 E-ISBN: 978 1 908818 36 2 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568336

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13


Medical science and technology, cancer research NEW 21st Century quality management and good management practices Value added compliance for the pharmaceutical and biotechnology industry

MEDICAL SCIENCE AND TECHNOLOGY, CANCER RESEARCH

NEW Lean biomanufacturing Creating value through innovative bioprocessing approaches

NEW Innovative brain tumor therapy

S Williams, Consultant, Australia

N J Smart, Smart Consulting Group, USA

Woodhead Publishing Series in Biomedicine No. 31

Woodhead Publishing Series in Biomedicine No. 37

21st Century quality management and good management practices is a practical guide on how to apply 21st century principles in the pharmaceutical and biotechnology workplace. The book includes simple understandable examples and case studies on modern compliance. The book serves as a practitioner’s guide and is an ideal companion for pharmaceutical and biotechnology industry professionals and students studying quality management and GMP compliance. CONTENTS

International rules and regulations in the life science industry; Pharmaceutical quality management and quality systems (ICH Q10); Fundamentals of good manufacturing practices (GMP); Validation; Pharmaceutical quality risk management (ICH Q9); Building quality into products (ICH Q8 and QbD); Process control and process analytical technology; CAPA, failure investigation and root cause analysis; Effective training and education; Behavioural GMPs, deviations and human error reduction; Supply chain integrity; Compliance auditing and product reviews.

250 pages 234 x 156mm (6 x 9) hardback Q2 2015 ISBN: 978 1 907568 50 3 E-ISBN: 978 1 908818 56 0 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568503

NEW Stem cell bioprocessing For cellular therapy, diagnostics and drug development T G Fernandes, M M Diogo and J M S Cabral, Instituto Superior Técnico (IST), Technical University of Lisbon, Portugal

The objective of this book is to re-visit lean principles and then apply them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful. The emphasis of the book is to approach the subject from a pharmaceutical practitioner’s point of view, rather than to create another generic treatise on lean manufacturing, of which there are ample editions in the marketplace already. CONTENTS

An introduction to lean biomanufacturing; Lean technologies/methods to be applied to biomanufacturing; Creation, execution and implementation of the Transition Plan; Issues and problems for the biopharmaceutical industry that make the situation challenging; Developing a lean approach to biopharmaceutical processes; The contribution of simulation models in the development of lean biopharmaceutical processes; Integration of biomanufacturing with lean laboratory operations; Lean compliance and considerations connected with enabling lean manufacturing; Ready to use technologies and their role in lean biomanufacturing.

384 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 78 7 E-ISBN: 978 1 908818 40 9 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568787

Woodhead Publishing Series in Biomedicine No. 40

Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion and/ or differentiation. Stem cell separation techniques are also discussed, aiming towards both isolation and purification of rare stem cell populations.

Nanoparticle-based therapeutic strategies G Caruso, L Merlo and M Caffo, University of Messina, Italy Woodhead Publishing Series in Biomedicine No. 67

Despite recent advances, therapeutic efforts have not been successful establishing a definitive strategy of treatment for brain gliomas, because of the presence of the blood-brain barrier. Innovative brain tumor therapy presents a synopsis of the studies on nanoparticles as ideal devices for brain tumor treatment. Their nanometric size, electrostatic charge, and lipophilic characteristics allow them to penetrate into the brain tissue freely. Promising in-vitro results have been reported, but remain to be validated in humans. This title focuses on the blood-brain barrier pathophysiology in brain tumors, and the possibilities of overcoming this with nanoparticle-based systems. Relevant patents of nanoparticles used as drug delivery carriers are also reported, as well as future scenarios in nanoparticles and stem cells. CONTENTS

Brief introduction on brain tumor epidemiology and state of the art in therapeutics; Blood brain barrier pathophysiology in brain tumors; Brain drug delivery attempts; Nanoparticles potential: Types, mechanisms of action, actual in vitro and animal studies, recent patents; Future scenarios: Nanoparticles and stem cells.

200 pages 234 x 156mm (6 x 9) hardback Q4 2014 ISBN: 978 1 907568 59 6 E-ISBN: 978 1 908818 74 4 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568596

Woodhead Publishing Online Woodhead Publishing Online is the only place the full collection of Woodhead e-books is available. Comprising over 1000 e-books and 17,000 chapters, the content provides an authoritative summary of key research, allowing readers to keep up-to-date with major trends. The site offers extensive features and functionality including no DRM, no limit to the number of concurrent users and a range of innovative purchase options.

Features

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Stem cells; Stem cell culture; Bioreactors for stem cell culture; Stem cell bioseparation; Micro-scale technologies for stem cell culture and separation; Stem cells and regenerative medicine.

• Regularly updated with new content PUBLISHING • Fast and powerful search tools • Extensive librarian support tools • Perpetual access - no ongoing maintenance fees • Hosted by Metapress

236 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 88 6 E-ISBN: 978 1 908818 30 0 £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568886

To see how Woodhead Publishing Online meets your research needs or to request a trial go to: www.woodheadpublishingonline.com or e-mail sales@woodheadpublishingonline.com

CONTENTS

14

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Medical science and technology, cancer research NEW Imported infectious diseases The impact in developed countries

NEW Medical education, training and care delivery in a virtual world

NEW Electroporation-based therapies for cancer

F Cobo, Hospital de Poniente, Spain

K Kahol, Arizona State University, USA

From basics to clinical applications

Woodhead Publishing Series in Biomedicine No. 66

Woodhead Publishing Series in Biomedicine No. 64

Edited by R Sundararajan, Purdue University, USA

The increase of immigrant population in developed countries (mainly in Europe and North America) together with an important increase of international travel worldwide are the two most important causes that have contributed to the introduction and diagnosis of imported/tropical infectious diseases in these countries. These factors have had an important impact in developed countries in both social and economic aspects. Imported infectious diseases focuses not only on describing the infections, but also in evaluating the current epidemiology, the economic and social impact and the possibility to apply immunization measures and vaccines. The main purpose of this book is to give an overview of the current most important and frequent imported infectious diseases in developed countries. The first chapter informs about the medical services that are being offered to the immigrants in the main developed countries depending on the legal situation. Following chapters describe the main surveillance systems for these kinds of diseases, mainly in Europe and North America. Finally, remaining chapters contain sections on epidemiology, pathogenesis, clinical features, diagnosis, treatment and prevention.

Medical education, training and care delivery in a virtual world provides a one-stop shop for educators, universities and researchers looking to employ virtual worlds for delivering medical education, training and employ virtual worlds for clinical purposes. The book provides theoretical basis and practical resources for virtual-environment-driven medical education and healthcare.

Woodhead Publishing Series in Biomedicine No. 49

CONTENTS

The recent emphasis in biomedical research on translational biology and personalized medicine is revolutionizing conceptual and experimental approaches to understanding and improving human health. Translational biology in medicine begins with an introduction to experimental model systems for disease, such as cell lines, primary cells, stem cells and animal models for disease, followed by a systematic description of genetic and genomic profiling and biomarker validation currently used in biomedical research. Examples of translation studies that have used these models and methods are presented, including studies in aging, tissue repair and chronic infection, each with an emphasis on how personalized medicine is transforming biomedicine.

Epidemiology; Surveillance systems in developed countries; Febrile syndrome in immigrants and travelers; Diarrhoea Syndrome; Current status of malaria; Filariasis; Schistosomiasis: Bilharziasis; Strongyloidiasis; Trypanosomiasis; Taeniasis and neurocysticercosis; HIV infection; Syphilis; Tuberculosis: The problem of multirresistance; Viral hepatitis; Leishmaniasis; Main causes of viral hemorrhagic fever; Arthropod-borne viruses affecting the central nervous system; Impact of imported infections in health care providers; Prophylaxis, immunisation and vaccination.

200 pages 234 x 156mm (6 x 9) hardback Q4 2014 ISBN: 978 1 907568 57 2 E-ISBN: 978 1 908818 73 7 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568572

CONTENTS

Introduction to virtual worlds; Virtual worlds: Some examples; Techniques; Setting the virtual universe; Setting your avatars; Setting the interactions; Meetings in virtual worlds; Applications; Training for technical and cognitive skills in virtual worlds; Team training in virtual environments; Validating virtual world training; Delivery of clinical care through virtual worlds: Guidelines, challenges and opportunities; Ethical and financial issues of virtual worlds.

220 pages 234 x 156mm (6 x 9) hardback Q3 2015 ISBN: 978 1 907568 03 9 E-ISBN: 978 1 908818 52 2 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568039

NEW Translational biology in medicine M Montano, Boston Medical Center, USA Woodhead Publishing Series in Biomedicine No. 41

CONTENTS

Model systems for disease: C.elegans; Mouse; Rhesus macaque; Mammalian cell lines; Primary cells; Adult stem cells and induced pluripotent stem (iPS) cells; Genomic and genetic profiling: Signatures for infection; Chronic inflammatory disease; Cancer risk; Accelerated aging and longevity; Blood biomarkers: An overview of existing serum test strategies for disease severity; Risk for progression; Therapeutic benchmark targets; Examples of translational models and methods in studies of human aging, muscle tissue repair, and chronic infection; Bioethical considerations in translational study design and bioethical considerations in biomedical research; Concluding remarks and the future of personalized medicine.

200 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 42 8 E-ISBN: 978 1 908818 65 2 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568428

Electroporation-based therapies for cancer provides a comprehensive overview of electroporation-based clinical studies in the hospitals for various cancer treatments, including melanomas, head and neck cancers, chest wall breast carcinomas and colorectal cancers. It also looks at research studies in the lab using cell lines, primary cells, and animals. CONTENTS

Clinical electro-chemo-therapy for advanced superficial melanoma; Effective electro-chemo-therapy for chest wall recurrence of breast carcinoma; Electrochemotherapy - aspects of clinical experience; Low and high voltage electro-chemo-therapy for breast cancer: An in vitro model study; Electrically-enhanced proliferation control of cancerstem-cell-like adult human mesenchymal stem cells a novel modality of treatment; Why electroporation is a useful technique for cancer treatments; Electro-endocrine therapy for breast cancer; Electroporation of cervical and leukemia cancer cells; Targeted delivery of siRNA and other difficult to transfect molecules using electroporation; Nanosecond, low voltage pulses for electro-endocrine therapy; Low and high voltage electroporation of ovarian cancer cells; Irreversible electroporation; Electric field distribution study of malignant tumors.

250 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 15 2 E-ISBN: 978 1 908818 29 4 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568152

NEW Bioinformatics for biomedical science and clinical applications K-H Liang, LinKo Medical Center, Chang Gung Memorial Hospital, Taiwan R.O.C. Woodhead Publishing Series in Biomedicine No. 20

Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions. CONTENTS

Genomics; Transcriptomics; Proteomics; Systems biomedical science; Clinical developments.

170 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 44 2 E-ISBN: 978 1 908818 23 2 £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568442

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15


Nanoscience and technology in medicine NEW NMR metabolomics in cancer research

NANOSCIENCE AND TECHNOLOGY IN MEDICINE

Human papillomavirus infections

M Cuperlovic-Culf, National Research Council of Canada Institute for Information Technology, Canada

From the laboratory to clinical practice

Woodhead Publishing Series in Biomedicine No. 63

Woodhead Publishing Series in Biomedicine No. 14

NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. The book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer.

‘This succinct review of the various facets of HPV invection and disease will be very useful for the intended audiences interested in this subject...There are no comparable books.’

CONTENTS

Biology – Cancer metabolic phenotype; Experimental methodology; Metabolomics NMR data pre-processing – Analysis of individual spectrum; Metabolomics data analysis – Processing and analysis of a dataset; Dynamic metabolic profiling and metabolite network and pathways modelling; Biomarker discovery; NMR metabolomics application by cancer type; Perspectives.

446 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 84 8 E-ISBN: 978 1 908818 26 3 £155.00/US$255.00/€185.00 www.woodheadpublishing.com/9781907568848

NEW Nanoparticle-based approaches to targeting drugs for severe diseases

F Cobo, Hospital de Poniente, Spain

J L Arias, University of Granada, Spain

Doody’s Reviews Human papillomavirus (HPV) is one of the most common causes of sexually transmitted diseases worldwide, both in men and women. Human papillomavirus infections provides the scientific background needed to understand the natural history and pathogenesis of HPV infection and offers discussion of its clinical features, diagnosis, treatment and prevention. The book begins with chapters covering the epidemiology, virology, history and transmission of the infection, as well as its pathogenesis and clinical features. Following a discussion of the relationship between HPV and cancer, chapters in the second half of the book look at diagnosis, testing and treatment. The book concludes with detailed coverage of the prevention of HPV through worldwide vaccination programmes. CONTENTS

Allergens and respiratory pollutants The role of innate immunity Edited by M A Williams, United States Environmental Protection Agency, USA

Introduction and epidemiological data; Basic virology: Structure and nomenclature; Natural history and transmission: Anatomic distribution; Pathogenesis and clinical features; HPV infection and association with cancer; Diagnosis of HPV infection; Clinical utility of HPV testing; Treatment; Prevention: HPV vaccines.

168 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 74 9 E-ISBN: 978 1 908818 17 1 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568749

Woodhead Publishing Series in Biomedicine No. 4 CONTENTS

An introduction to allergic inflammation and the innate immune sensing of dangerous ambient pollutants by the dendritic cell; Asthma: Primary immunomodulatory pathways; Environmental lung injury and pattern recognition receptors; Asthma exacerbations: A paradigm of synergy between allergens, pollutants and viruses; Bronchial hyperresponsiveness and lung inflammation induced by allergic immune response and oxidative stress: Role of innate and adaptive immune responses; Effects of air pollutants on allergic sensitization through the airway; Particulate matter and oxidative stress: Dangerous partners in inflammation, vascular dysfunction and innate immunity; Diesel exhaust particles and the airway epithelial cell–dendritic cell interface in the control of immune homeostasis; Role of macrophages in adverse pulmonary effects of particulate pollutants; Particulate air pollution and vulnerability to respiratory infections in children; The intersection of respiratory syncytial virus infection, innate immunity and allergic lung disease; Interactions between allergens and dendritic cells: Pattern recognition receptors and their function in the pathogenesis of allergic respiratory diseases.

312 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 907568 54 1 E-ISBN: 978 1 908818 06 5 £112.50/US$185.00/€135.00 www.woodheadpublishing.com/9781907568541

16

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Woodhead Publishing Series in Biomedicine No. 47

Nanoparticle-based approaches to targeting drugs for severe diseases is devoted to the analysis of the latest developments in the use of passive and/or active targeting nanostrategies for controlling the biodistribution profiles of pharmacotherapy agents and special attention is given to recent advances in these engineering approaches. This book provides an in-depth and detailed analysis of the above problems, and a comprehensive discussion of the available solutions. It focuses on aspects of the formulation of drug nanocarriers, alongside characterisation techniques, toxicity issues, regulatory aspects, and marketing. CONTENTS

Integration of nanotechnology in pharmacotherapy; Nanostructures in drug delivery; Nano-engineering strategies for passive drug delivery and targeting; Nano-engineering strategies for ligand-mediated drug delivery and targeting; Nano-engineering strategies for stimuli-sensitive drug delivery and targeting; Nano-engineering strategies in theragnosis; Advanced nanomedicines against severe diseases.

300 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 11 4 E-ISBN: 978 1 908818 44 7 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568114

Nanoparticulate drug delivery Perspectives on the transition from laboratory to market V Patravale, Institute of Chemical Technology, India, P Dandekar and R Jain, Institute of Chemical Technology, India Woodhead Publishing Series in Biomedicine No. 17

Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems, operating at scales of billionths of a metre, from laboratory into a commercially viable sector. The book describes the need for various types of nanoparticulate drug delivery systems in different application areas, and assesses the challenges to society associated with their advance. CONTENTS

Nanoparticulate systems as drug carriers: The need; Nanoparticles as drug carriers; Characterization techniques for nanoparticulate carriers; Nanotoxicology: Evaluating toxicity potential of drug-nanoparticles; Regulatory aspects of nanoparticulate drug delivery systems; Clinical trials and industrial aspects; Case studies: Nano-systems in the market.

244 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 98 5 E-ISBN: 978 1 908818 19 5 £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568985

Available / will be available on Woodhead Publishing Online


Pharmaceutical science/technology, drug delivery PHARMACEUTICAL SCIENCE/ TECHNOLOGY, DRUG DELIVERY NEW Clinical research in paediatric psychopharmacology A practical guide P Auby, Corporate ICR France & Paediatrics, France Woodhead Publishing Series in Biomedicine No. 27

Clinical research in paediatric psychopharmacology covers ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. The book is written and organised with the aim of being a practical guide, providing both an overview of clinical research in paediatric psychopharmacology and practical points to consider when developing clinical research in this field. CONTENTS

Historical perspective; Regulatory changing environment - US; EU; And WHO; Scientific - state of the art - child and adolescent psychopharmacology at the beginning of the 21st century; Ethical aspects of research in paediatric psychopharmacology; Clinical development; Patients and family perspectives; Intercultural aspects; Future methodological perspectives; Future of child and adolescent psychopharmacological research.

220 pages 234 x 156mm (6 x 9) hardback Q4 2014 ISBN: 978 1 907568 24 4 E-ISBN: 978 1 908818 60 7 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568244

NEW Controlled drug delivery The role of self-assembling multi-task excipients

NEW Advancement in carrier-based drug delivery

NEW Clinical trial management

S K Jain, Central University and A Jain, Adina Institute of Pharmaceutical Sciences, India

U Sahoo, India for Chiltern and D Sawant, Clinical Monitoring, India

Woodhead Publishing Series in Biomedicine No. 56

Woodhead Publishing Series in Biomedicine No. 35

Concerned with the scientific and technological aspects of the various drug delivery systems. Pharmaceutics is one of the most diverse areas in pharmaceutical science. Advancement in carrier-based drug delivery presents emerging trends in specific drug delivery, including advanced concepts in the design and fabrication of new drug delivery systems and targeting mechanisms. This title includes the influence of drug properties, route of administration, and PK/ PD of drugs. The book is structured into four sections, and discusses general considerations in drug delivery, including physiological and biochemical barriers to drug delivery; carrier-based drug delivery systems, including liposomes, niosomes and ethiosomes; drug targeting approaches, including organ-based drug targeting; and regulatory aspects for new drug delivery techniques.

Clinical trial management is designed to show the various activities that are involved in clinical trials and understand their processes, which are essential for planning and implementing a successful clinical trial. This book also facilitates the understanding of the importance of ethics in clinical studies and the evolution of various guidelines, rules and regulations for the management of a clinical trial. Recruitment and retention of valuable patients are critical to the success of a clinical trial and hence pose a large number of challenges for the management team to complete the trial in multiple countries with the desired number of patients enrolled in time.

CONTENTS

Section 1 General considerations in drug delivery: General considerations and biochemical concepts in drug delivery; Physiological and biochemical barrier to drug delivery; Influence of drug properties and routes of drug administration; Biopharmaceuticals and pharmacokinetics considerations of drug delivery system; Applications of pharmacokinetics and pharmacodynamics in design of drug delivery system. Section 2 Carrier-based drug delivery system: Liposomes; Niosomes; Ethiosomes; Pharmacosomes; Phytosomes; Nanoparticles; Dendrimers; Carbon nanotubes; Resealed erythrocytes; Aquasomes; Micro/ nanospheres; Micro/nanoemulsions. Section 3 Drug targeting approaches: Molecular consideration of drug targeting; Various approaches of drug targeting including chemical and physical approaches; Organ-based drug targeting. Section 4 Regulatory aspects for new drug delivery.

200 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 49 7 E-ISBN: 978 1 908818 69 0 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568497

An overview

CONTENTS

Project management; Inspection and audits; Regulatory affairs; Pharmacovigilance; Medical affairs; Patient recruitment and retention; Ethics in clinical research.

250 pages 234 x 156mm (6 x 9) hardback Q3 2015 ISBN: 978 1 907568 66 4 E-ISBN: 978 1 908818 58 4 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568664

NEW The life-cycle of pharmaceuticals in the environment R Braund and B M Peake, University of Otago, New Zealand Woodhead Publishing Series in Biomedicine No. 51

In complex macromolecules, minor modifications can generate major changes, due to self-assembling capacities of macromolecular or supramolecular networks. Controlled drug delivery highlights how the multifunctionality of several materials can be achieved and valorized for pharmaceutical and biopharmaceutical applications.

The life-cycle of pharmaceuticals in the environment identifies pathways of entry of pharmaceuticals into the environment beginning with the role of global prescribing and disposal practices. It then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and potable water. Methods currently available to degrade pharmaceuticals in the natural waters are discussed and some of their ecotoxicological impacts are reviewed. Future considerations and the growing concept of product stewardship are also examined.

CONTENTS

CONTENTS

M A Mateescu, P Ispas-Szabo and E Assaad, University of Quebec, Canada Woodhead Publishing Series in Biomedicine No. 58

The concept of self-assembling; Starch and derivatives as pharmaceutical excipients; Chitosan and derivatives as biomaterials and as pharmaceutical excipients; Polyelectrolyte complexes as excipients for oral administration; Natural semi-synthetic and synthetic materials; Protein-protein associative interactions and their involvement in bioformulations; Self-assembling materials, implants and xenografts; Conclusions and perspectives.

200 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 45 9 E-ISBN: 978 1 908818 67 6 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568459

Prescribing practices of pharmaceuticals; Disposal practices of pharmaceuticals; Pharmaceutical levels detected within natural waters; Removal and degradation of pharmaceuticals in natural waters; Environmental impact; Conclusions/future policies.

270 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 25 1 E-ISBN: 978 1 908818 45 4 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568251

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17


Pharmaceutical science/technology, drug delivery NEW Handbook of cosmeceutical excipients

NEW Therapeutic risk management of medicines

Y H Kwan, Duke-NUS Graduate Medical School Singapore, Y K Tung and J S Kochhar, National University of Singapore, A-L Poh, Parkway Hospitals Singapore Pte Ltd and L Kang, National University of Singapore, Singapore

S J Mayall and A K Banerjee, Pope Woodhead & Associates, UK

Woodhead Publishing Series in Biomedicine No. 65

Cosmeceuticals are the latest additions to the health industry and have an ever-expanding market. They are considered to be a marriage between cosmetics and drugs and are defined as preparations applied on the body that may modify the physiological functions of the skin. However, as more cosmeceuticals are launched in the market and more types of drugs are incorporated into the formulation, the composition of cosmeceuticals is becoming more complex. Handbook of cosmeceutical excipients summarises the current evidence relating to cosmeceuticals’ side effects and highlights the important information that practitioners and consumers need to know, as well as ways to avoid the adverse effects of the excipients. Handbook of cosmeceutical excipients includes chapters covering topics such as the history of cosmeceuticals and the laws that regulate them, skin permeation, carcinogenicity as a systemic adverse effect and dermatitis as a topical adverse effect. It concludes with an appendix that gives brief information on the potency and permeability of common ingredients in cosmeceuticals. The appendix aims to highlight the maximum allowable quantity of each ingredient to ensure product safety for consumers. The appendix was prepared by compiling the ingredients of 257 products containing more than 500 compounds, collected from a hospital pharmacy in Singapore. CONTENTS

History and opportunities: Historical background of cosmeceuticals and its impact in current world; Concept of excipient safety: Who coined the term?; How big is the industry?; How many new products per year?; Law: Regulation in US and Role of US FDA in cosmeceuticals; Regulation in Europe; Regulation in ASEAN; A comparison of their differences; Skin permeation: Overview of the concept of flux; Translation of animal to human dose; Calculating of limits of excipients to prevent related adverse effects; Systemic effect: Cancer: Impact of carcinogenicity of excipients; Evidences available in current literature; Mechanism of carcinogenicity; Ways to prevent carcinogenicity of excipients. Local effect: Dermatitis: Impact of dermatitis of excipients; Evidences available in current literature; Mechanism of dermatitis; Prevention; Appendix: Brief description of each excipient.

200 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 53 4 E-ISBN: 978 1 908818 71 3 Approx. £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568534

Woodhead Publishing Series in Biomedicine No. 30

Legislation has evolved rapidly over the last decade and Therapeutic risk management of medicines is an authoritative, yet practical, guide on planning, writing, implementing and evaluating risk management plans for medicines globally. The book also includes chapters on the historical development, lessons from other industries, the regulatory and health authority perspective and public communication of benefit risk. This topic is of critical importance not only to the pharmaceutical and biotechnology industry, but also prescribers, pharmacists, regulators and healthcare policymakers. CONTENTS

Introduction and historical background of risk management plans; EU-RMP (Risk Management Plan); USA REMS (Risk Evaluation and Mitigation Strategies); Safety specification; Pharmacovigilance planning; Assessing the need for risk minimization; Risk minimization tools; Implementation of RMPs and REMS; Evaluation of RMPs and REMS; Developmental risk management plans; Effectively negotiating with the health authorities; Public communication of benefit risk.

250 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 1 907568 48 0 E-ISBN: 978 1 908818 27 0 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568480

NEW Orphan drugs Understanding the rare disease market and its dynamics E Hernberg-Stahl, Late Phase Solutions Europe AB, Sweden and M Reljanovic Woodhead Publishing Series in Biomedicine No. 46

There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. Orphan drugs provides a comprehensive overview of strategy, key activities and considerations of how to bring an orphan drug from concept to the market and make it available to patients. It is a source of updated information, news and trends for those who are already active in this fast-moving field. CONTENTS

Orphan drugs and orphan drug legislation; Characteristics of rare diseases; Patient network and advocacy groups; Organisations and networks dedicated to rare diseases and orphan drugs; Policies and research funding; Designing robust clinical trials for orphan drugs; Market access procedures for orphan drugs.

334 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 09 1 E-ISBN: 978 1 908818 39 3 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568091

An introduction to pharmaceutical sciences

NEW Oral delivery of insulin

Production, chemistry, techniques and technology

T A Sonia and C P Sharma, Sree Chitra Tirunal Institute for Medical Sciences and Technology, India

J Roy, Mississippi University for Women, USA Woodhead Publishing Series in Biomedicine No. 6

Woodhead Publishing Series in Biomedicine No. 41

Diabetes Mellitus, a syndrome of disordered metabolism, characterised by abnormal elevation in blood glucose level, has become a life-threatening condition for many people. Current means of therapy for Diabetes Mellitus do not mimic the normal physiological pattern of insulin release. Oral delivery is the preferred route of administration due to its non-invasive nature. Oral delivery of insulin presents an overview of Diabetes Mellitus, and discusses the strategies and techniques adopted for oral delivery of insulin. CONTENTS

Diabetes Mellitus; Different routes of administration of insulin; Oral insulin delivery: Challenges and strategies; Experimental techniques involved in the development of oral insulin carrier; Lipids; Inorganic nanoparticles and polymers in oral insulin delivery; Summary and future perspectives for oral delivery of insulin.

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. CONTENTS

Career prospects in the pharmaceutical industry; Drugs, medicines, and regulatory authorities; Bulk drugs or active pharmaceutical ingredients; Formulated drugs 1; Formulated drugs 2; The stability of medicines; Quality assurance in medicines; Pharmacological concepts and drugs; The top five most common or long-selling drugs; Life-style drugs, statins, and COX-2 drugs; Counterfeit drugs and drug abuse; New pharmaceutical technology and pharmaceuticals; Future prospects for the pharmaceutical industry; Pharmaceutical case studies.

446 pages 234 x 156mm (6 x 9) paperback 2011 ISBN: 978 1 907568 52 7 E-ISBN: 978 1 908818 04 1 £57.50/US$95.00/€70.00 www.woodheadpublishing.com/9781907568527

270 pages 234 x 156mm (6 x 9) hardback Q1 2015 ISBN: 978 1 907568 47 3 E-ISBN: 978 1 908818 68 3 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568473

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Pharmaceutical science/technology, drug delivery NEW Nanoparticle-based approaches to targeting drugs for severe diseases

NEW Ocular transporters and receptors

NEW Transporters in drug discovery and development

Their role in drug delivery

Detailed concepts and best practice

J L Arias, University of Granada, Spain

Edited by A K Mitra, University of Missouri, USA

Y Lai, A major US pharmaceutical company, USA

Woodhead Publishing Series in Biomedicine No. 39

Woodhead Publishing Series in Biomedicine No. 50

Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this book the cutting edge research being carried out in this field is compiled and summarized. The book focuses on key areas, including the anatomy and physiology of the eye, biology of ocular transporters and receptors, techniques in characterization of transporters and receptors, transporters and receptors in the anterior and posterior segment in the eye, the role of ocular transporters and receptors in drug delivery, and transporter-metabolism interplay in the eye.

Written by a leading researcher in the field, Transporters in drug discovery and development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development.

Woodhead Publishing Series in Biomedicine No. 47

Nanoparticle-based approaches to targeting drugs for severe diseases is devoted to the analysis of the latest developments in the use of passive and/or active targeting nanostrategies for controlling the biodistribution profiles of pharmacotherapy agents and special attention is given to recent advances in these engineering approaches: specifically, to target nanomedicines against severe diseases, and to the development of multifunctional nanoplatforms for combined selective diagnosis and effective pharmacotherapy. This book provides an in-depth and detailed analysis of the above problems, and a comprehensive discussion of the available solutions. It focuses on aspects of the formulation of drug nanocarriers, alongside characterisation techniques, toxicity issues, regulatory aspects, and marketing. CONTENTS

Integration of nanotechnology in pharmacotherapy; Nanostructures in drug delivery; Nano-engineering strategies for passive drug delivery and targeting; Nano-engineering strategies for ligand-mediated drug delivery and targeting; Nano-engineering strategies for stimuli-sensitive drug delivery and targeting; Nano-engineering strategies in theragnosis; Advanced nanomedicines against severe diseases.

300 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 907568 11 4 E-ISBN: 978 1 908818 44 7 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568114

CONTENTS

Eye: Anatomy, physiology and barriers to drug delivery; Biology of ocular transporters and receptors; Characterization of ocular transporters and receptors; Transporters and receptors in the anterior segment of the eye; Transporters and receptors in the posterior segment of the eye; Transporters in subcellular organelles: Regulation, characterization and role in ocular drug delivery; Transporters in drug discovery and delivery: A new paradigm in ocular drug design; Transporter-metabolism interplay in the eye.

250 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 86 2 E-ISBN: 978 1 908818 31 7 Approx. £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781907568862

Woodhead Publishing Online Woodhead Publishing Online is the only place the full collection of Woodhead e-books is available. Comprising over 1000 e-books and 17,000 chapters, the content provides an authoritative summary of key research, allowing readers to keep up-to-date with major trends. The site offers extensive features and functionality including no DRM, no limit to the number of concurrent users and a range of innovative purchase options.

Features

WOODHEAD

• Regularly updated with new content PUBLISHING • Fast and powerful search tools • Extensive librarian support tools • Perpetual access - no ongoing maintenance fees • Hosted by Metapress

CONTENTS

Membrane transporters and the diseases corresponding to functional defects; P-glycoprotein (P-gp/MDR1)/ ABCB1; Multidrug resistance- associated protein 2 (MRP2/ ABCC2); Breast cancer resistance protein (BCRP)/ABCG2; The bile salt export pump (BSEP/ABCB11); Organic aniontransporting polypeptides (OATPs/SLCOs); Organic anion, organic cation and zwitterion transporters of the SLC22 and SLC47 superfamily (OATs, OCTs, OCTNs and MATEs); Drug transporters in drug discovery and development; Transporter study methodologies.

780 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 21 3 E-ISBN: 978 1 908818 28 7 Approx. £180.00/US$295.00/€215.00 www.woodheadpublishing.com/9781907568213

NEW Drug-biomembrane interaction studies The application of calorimetric techniques Edited by R Pignatello, University of Catania, Italy Woodhead Publishing Series in Biomedicine No. 45

Drug-biomembrane interaction studies is written by scientists renowned for their work in the field of DSC applications to drug development and delivery, and especially to drug-biomembrane interaction studies. The issues above are clarified, and any areas where uncertainties remain are highlighted and assessed. The book combines insights from biochemistry and physiology with those from structural biology, nanotechnology and bio-thermodynamics, to obtain a complete depiction of cell membranes and their functions. CONTENTS

Biological membranes and their role in physio- pathological conditions; Biomembrane models; Analytical methods for studying drug–biomembrane interactions; Differential scanning calorimetry (DSC): Theoretical fundamentals; DSC: History, instruments and devices; DSC in drug–biomembrane interaction studies; DSC applications: Macromolecules; DSC applications: Nucleic acids and membrane interactions; Nonsteroidal anti- infl ammatory drugs; Antimicrobial agents; Drug delivery systems: Drug nanocarriers.

440 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 05 3 E-ISBN: 978 1 908818 34 8 £155.00/US$255.00/€185.00 www.woodheadpublishing.com/9781907568053

To see how Woodhead Publishing Online meets your research needs or to request a trial go to: www.woodheadpublishingonline.com or e-mail sales@woodheadpublishingonline.com

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19


Pharmaceutical science/technology, drug delivery NEW Sterility, sterilisation and sterility assurance for pharmaceuticals

NEW Formulation tools for pharmaceutical development Edited by J E Aguilar

Technology, validation and current regulations

NEW Computer-aided applications in pharmaceutical technology

Woodhead Publishing Series in Biomedicine No. 44

Edited by J Djuris, University of Belgrade, Serbia

The range of innovative tools described in this book permit the evaluation of the proposed formulation which provides data for a better understanding of the process and the product which supports the development of medicines according to recent new strategies of ‘Quality by Design’ and ‘New Strategy for Process Validation Guidelines’. The tools included in this book are: expert systems; artificial intelligence tools, neuro-fuzzy tools, multimedia tools, artificial neural networks, neurofuzzylogic and genetic programming, plus other mathematical tools.

Woodhead Publishing Series in Biomedicine No. 52

T Sandle, Bio Products Laboratory, UK Woodhead Publishing Series in Biomedicine No. 32

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.

CONTENTS

Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: A heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push–pull osmotic pump tablets containing poorly water- soluble drugs; SeDeM Diagram: An expert system for preformulation, characterization and optimization of tablets obtained by direct compression; New SeDeMODT expert system: An expert system for formulation of orodispersible tablets obtained by direct compression; 3-D cellular automata in computer-aided design of pharmaceutical formulations: Mathematical concept and F-CAD software; OXPIRT: Ontology- based eXpert system for Production of a generic Immediate Release Tablet; Optimisation of compression parameters with AI-based mathematical models.

304 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 99 2 E-ISBN: 978 1 908818 50 8 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568992

CONTENTS

Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology and chemometric methods, with emphasis on their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps) computeraided biopharmaceutical characterization, as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. CONTENTS

Quality-by-design in pharmaceutical development; Computer-aided formulation development; Experimental design application and interpretation in pharmaceutical technology; Chemometric methods application in pharmaceutical products and processes analysis and control; Neural computing in pharmaceutical products and process development; Computer-aided biopharmaceutical characterization: Gastrointestinal absorption simulation; Computational fluid dynamics: Applications in pharmaceutical technology.

300 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 27 5 E-ISBN: 978 1 908818 32 4 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568275

Sterility, sterilisation and microorganisms; Pyrogenicity and bacterial endotoxins; Regulatory requirements and good manufacturing practices; Gamma radiation; E-beam; Dry heat sterilisation; Steam sterilisation; Sterilisation by gas; Vapour sterilisation; Sterile filtration; Depyrogenation; Cleanrooms; Aseptic processing; Media simulation; Biological indicators; Sterility testing; Auditing; New sterilisation techniques.

362 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 38 1 E-ISBN: 978 1 908818 63 8 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781907568381

20

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Pharmaceutical science/technology, drug delivery Therapeutic antibody engineering

Clinical research in Asia

Therapeutic protein drug products

Current and future advances driving the strongest growth area in the pharmaceutical industry

Opportunities and challenges

Practical approaches to formulation in the laboratory, manufacturing, and the clinic

U Sahoo, Chiltern, India

W R Strohl, Johnson & Johnson Biotechnology Center of Excellence and L M Strohl, Medical Illustrator, USA Woodhead Publishing Series in Biomedicine No. 11 ‘An excellent balance between readability and depth of material.... The book is well referenced and provides plentiful opportunities to continue subject-specific learning.’

mAbs Journal ‘An excellent book describing many aspects of therapeutic antibody generation and the current market share of these drugs. It is an up-to-date evaluation of their production and clinical utility.’

Doody’s Book Reviews Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on candidates of the future. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. In the following chapters, the book covers a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. CONTENTS

Introduction to biologics and monoclonal antibodies; Value proposition for therapeutic monoclonal antibodies and Fc fusion proteins; Antibody structure–function relationships; Fundamental technologies for antibody engineering; Sources of antibody variable chains; Variable chain engineering – humanization and optimization approaches; Antibody interactions with the immune system; Monoclonal antibody targets and mechanisms of action; Therapeutic antibody classes; Antibody Fc engineering for optimal antibody performance; IgG glycans and glyco-engineering; Antibody fragments as therapeutics; Multiple antibody and multispecificity approaches; FcFPs and similar constructs using Fc; Antibody-drug conjugates; Development issues: Antibody stability, developability, immunogenicity, and comparability; Interactions of human IgGs with non-human systems; Cell line development; Issues facing therapeutic monoclonal antibodies for the future.

Woodhead Publishing Series in Biomedicine No. 10 ‘An important contribution to the field of global research ethics’

Doody’s Book Reviews Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). CONTENTS

Clinical research in Asia: A brief overview; Clinical research in Japan; Clinical research in India; Clinical research in China; Clinical research in South Korea; Clinical research in Taiwan; Clinical research in Singapore; Clinical research in Thailand; Clinical research in Malaysia; Clinical research in Hong Kong; Clinical research in the Philippines, Indonesia and Vietnam; Conclusions.

412 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 00 8 E-ISBN: 978 1 908818 13 3 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568008

Edited by B K Meyer, Merck Research Laboratories (MRL), USA Woodhead Publishing Series in Biomedicine No. 8

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. CONTENTS

Commercial therapeutic protein drug products; A formulation method to improve the physical stability of macromolecularbased drug products; Properties of protein formulations; Material and process compatibility testing; Compounding and filling: Drug substance to drug product; Administration in the clinic; Regulatory guidelines for the development of a biotechnology drug product.

200 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 18 3 E-ISBN: 978 1 908818 10 2 £112.50/US$185.00/€135.00 www.woodheadpublishing.com/9781907568183

696 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 37 4 E-ISBN: 978 1 908818 09 6 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781907568374

Find us on Twitter: @WoodheadTweets, Facebook at: /WoodheadPublishingLimited and Linkedin: /company/woodhead-publishing-limited

21


Regenerative medicine Stem cell sciences

Applications

REGENERATIVE MEDICINE

STEM CELL SCIENCES

APPLICATIONS

Developments in tissue engineered and regenerative medicine products

NEW Stem cell bioprocessing

NEW Joint replacement technology

For cellular therapy, diagnostics and drug development

Second edition

A practical approach J Basu and J W Ludlow, Tengion Inc, USA Woodhead Publishing Series in Biomaterials No. 48

Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized. Roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete ‘how-to’ manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing. CONTENTS

Overview of tissue engineering/regenerative medicine; Cells; Biomaterials for TE/RM products; Neo-Bladder: A foundational technology platform for tubular organ regeneration; Neo-Urinary Conduit™; Tissue engineering of non-bladder tubular organs; Tissue engineering of solid organs; Regulatory and quality control; Pre-clinical and clinical evaluation of TE/RM products; Manufacturing; Intellectual property.

226 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 76 3 E-ISBN: 978 1 908818 11 9 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568763

T G Fernandes, M M Diogo and J M S Cabral, Instituto Superior Técnico (IST), Technical University of Lisbon, Portugal Woodhead Publishing Series in Biomedicine No. 40

Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion and/ or differentiation. Stem cell separation techniques are also discussed, aiming towards both isolation and purification of rare stem cell populations. CONTENTS

Stem cells; Stem cell culture; Bioreactors for stem cell culture; Stem cell bioseparation; Micro-scale technologies for stem cell culture and separation; Stem cells and regenerative medicine.

236 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 907568 88 6 E-ISBN: 978 1 908818 30 0 £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9781907568886

Commercializing the stem cell sciences O Harvey, University of Sydney, Australia Woodhead Publishing Series in Biomedicine No. 12

Commercializing the stem cell sciences offers a comparative analysis of the commercial methods adopted in the global stem cell industries. It seeks to establish whether there is an optimum commercial model and to examine what emerging companies can learn from their predecessors. Following an introduction to stem cell sciences and the problems involved in their commercialization, the book begins with a discussion of stem cell treatments from a global perspective, and the role of innovation in the commercialization of biotechnology in general. In the second half of the book, chapters focus on the different strategies that can be employed and their relative risks and values, before a conclusion that looks at potential new developments in the field.

Edited by P A Revell, UCL, UK Woodhead Publishing Series in Biomaterials No. 80

Joint replacement has brought improved quality of life to millions of patients and is regarded a standard procedure for the treatment of joint degradation, particularly as a result of osteoarthritis. Its continued success depends on effective collaboration between clinicians and researchers across many different areas in science and medicine. In response to ongoing demand a great deal of research is continually being undertaken, resulting in significant improvements in both the biomaterials and design of implants. This second edition provides an updated comprehensive review of recent developments in joint replacement technology. This book covers the most pertinent materials science and engineering issues in depth, in addition to a review of the specific joints, biological and mechanical issues and fixation techniques. CONTENTS

Part 1 Introduction to joint replacement technology: Biomechanics of joints; Tribology in joint replacement; Biomaterials and the chemical environment of the body. Part 2 Materials and techniques in joint replacement: Metals for joint replacement; Ceramics for joint replacement; Joint bearing surfaces and replacement joint design; Cementless fixation techniques in joint replacement; Bone cement fixation: Acrylic cements. Part 3 Biological and mechanical issues in joint replacement: The healing response to implants used in joint replacement; Biological causes of prosthetic joint failure; Failure mechanisms in joint replacement; Tribology and corrosion in metal-on metal hip joint replacements; Predicting the lifetime of joints; Imaging of joint replacements. Part 4 Replacing specific joints: Hip replacement: Clinical perspectives; Knee replacement: clinical perspectives; Intervertebral disc joint replacement technology; Overview of total replacement of the first metatarso-phalangeal joint; Replacing shoulder joints; Replacing elbow joints; Replacing finger and toe joints with pyrolytic carbon.

630 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 0 85709 841 2 E-ISBN: 978 0 85709 847 4 Approx. £180.00/US$295.00/€215.00 www.woodheadpublishing.com/9780857098412

CONTENTS

Introduction: Stem cell science, biotechnology and the problem of commercialization; Stem cell treatments in a global marketplace; The role of innovation systems in the commercialization of biotechnology; Low-risk, low-value: Adult stem cells; High-risk, high-value: Embryonic stem cells; Low-risk, low-value: iPS cells; What does the future hold?

212 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 60 2 E-ISBN: 978 1 908818 14 0 £102.50/US$170.00/€125.00 www.woodheadpublishing.com/9781907568602

22

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Applications NEW Cardiac regeneration and repair

NEW Cardiac regeneration and repair

Volume 1: Pathology and therapies

Volume 2: Biomaterials and tissue engineering

Edited by R-K Li and R D Weisel, University of Toronto, Canada Woodhead Publishing Series in Biomaterials No. 71

Heart disease is the leading cause of death in the UK and the United States. For those people who survive heart disease, few victims recover completely. Cell therapies, tissue engineering and biomaterials technologies have advanced and now offer the potential to reverse the damage caused by heart disease. Volume 1 provides readers with comprehensive information on the pathology of heart disease and the cell therapies available. Opening chapters look at cardiac pathology and current therapies. Further chapters present gene and protein therapies for regeneration. The text then discusses cell therapies for cardiac regeneration whilst final chapters review clinical considerations of stem cell therapies. CONTENTS

Part 1 The pathogenesis of congestive heart failure: Cardiac matrix remodeling and heart failure; Cardiac biomechanics and heart dysfunction; Modifying matrix remodeling to prevent heart failure. Part 2 Cell therapy for cardiac regeneration and repair: Optimal cells for cardiac repair and regeneration; Cell delivery routes for cardiac stem cell therapy; Cell therapy to regenerate the ischemic heart; Cell therapy for cardiac repair – bench to bedside and back; Recent advances in cardiac stem cell therapy to restore left ventricular function; Monitoring myocardial functional regeneration following cardiac stem cell application; Feasibility of allogeneic stem cells for heart regeneration; Bone marrow cells and their role in cardiac repair after myocardial infarction. Part 3 Stem cells for cardiac regeneration and repair: Cardiac cell therapy to restore contracting elements; Human embryonic stem cells (hESCs) for heart regeneration; Human pluripotent stem cells (hPSCs) for heart regeneration; Cardiac cell therapy: Current status and future trends. Part 4 Gene therapy for cardiac regeneration and repair: Stem cell and gene therapy for cardiac regeneration; Ultrasound-targeted cardiovascular gene therapy.

448 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 658 6 E-ISBN: 978 0 85709 670 8 Approx. £150.00/US$250.00/€180.00 www.woodheadpublishing.com/9780857096586

Edited by R-K Li and R D Weisel, University of Toronto, Canada Woodhead Publishing Series in Biomaterials No. 72

Volume 2 of this important set provides readers with comprehensive information on biomaterials and tissue engineering as strategies for the repair and regeneration of the heart. The book begins with an introduction to the field. A first set of chapters look at biomaterials for regeneration and repair of the heart. Further chapters discuss tissue engineering strategies for the regeneration and repair of the heart, whilst the final chapters review vascular modelling and regeneration. CONTENTS

Part 1 Biomaterials for cardiac regeneration and repair: Nanotechnology and nanomaterials for cardiac repair; Hydrogels for cardiac repair; Injectable biomaterials for cardiac regeneration and repair; Biomaterials for enhancing endothelial progenitor cell (EPC) therapy for cardiac regeneration; Endothelial progenitor cell (EPC)-seeded intravascular stents. Part 2 Tissue engineering for cardiac regeneration and repair: Biomaterials and cells for cardiac tissue engineering; Decellularized biologic scaffolds for cardiac repair and regeneration; Biomaterial scaffolds for cardiac regeneration and repair derived from native heart matrix; Cell sheet engineering for cardiac repair and regeneration; Maturation of functional cardiac tissue patches; Vascularizing engineered tissues for in vivo and in vitro applications; Clinical considerations for cardiac tissue engineering. Part 3 Vascular remodelling for regeneration and repair: Aortic extra cellular matrix (ECM) remodelling; Cell-biomaterial interactions for blood vessel formation; Stem cells in tissue-engineered blood vessels for cardiac repair; Tissue-engineered cardiovascular grafts and novel applications of tissue engineering by self-assembly (TESA™).

528 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 659 3 E-ISBN: 978 0 85709 671 5 Approx. £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9780857096593

Biomaterials and devices for the circulatory system Edited by T Gourlay and R Black, University of Strathclyde, UK Woodhead Publishing Series in Biomaterials No. 27 CONTENTS

Part 1 Physiological responses to biomaterials: Tissue responses to implanted materials; Blood interface biomaterials; Biocompatibility of cardiovascular devices. Part 2 Clinical application of biomaterials: Developments in cardiovascular valve technology; Percutaneous cardiovascular valve replacement; Cardiopulmonary bypass technologies; Cardiovascular stents; Vascular implants for peripheral arterial bypass and aortic aneurysm repair. Part 3 Future developments: Nanotechnology and nanomedicine in cardiovascular therapy; Biomaterials in cardiac restoration therapy; Biosensor technology in the treatment of cardiovascular disease; Vascular tissue engineering.

400 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 464 7 E-ISBN: 978 0 85709 055 3 £147.50/US$245.00/€175.00 www.woodheadpublishing.com/9781845694647

NEW Silk biomaterials for tissue engineering and regenerative medicine Edited by S Kundu, Indian Institute of Technology Kharagpar, India Woodhead Publishing Series in Biomaterials No. 74

Silk has been used for centuries in medicine as sutures. The unique mechanical and chemical properties of this material and the ability to genetically tailor the protein has meant that this material is now being used increasingly for biomaterials and tissue engineering applications. This book discusses the properties and applications of silk for medical purposes. CONTENTS

Part 1 Fundamentals and properties of silk for biomedical applications: The history and origin of silk; Processing of Bombyx mori silk for biomedical applications; Silk nanostructures based on natural and self engineered assembly; Biochemical and biophysical properties of native Bombyx mori silk for tissue engineering applications; Structure and properties of Spider and silkworm silk for tissue scaffolds; Bio-response to silk sericin; Biodegradation of silk. Part 2 Silk for biomaterials, tissue engineering and regenerative medicine applications: Silk based biomaterials in tissue engineering and regenerative medicine; Non-mulberry Silk biomaterials in tissue engineering and regenerative medicine; Silk powder for regenerative medicine; Silk scaffolds for 3D tumour modelling; Silk hydrogels for tissue engineering and dual drug delivery; Silk biomaterials for Intervertebral disc tissue engineering; Silk scaffolds for dental tissue engineering; Silk for cardiac tissue engineering; Silk for dermal tissue engineering; Capillary growth in porous silk films; Pharmaceutical and Cosmeceutical Applications of Silk.

570 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 0 85709 699 9 E-ISBN: 978 0 85709 706 4 Approx. £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9780857096999

NEW Biomedical foams for tissue engineering applications Edited by P Netti, University of Naples and Italian Institute of Technology, Italy Woodhead Publishing Series in Biomaterials No. 76

This book provides readers with a comprehensive review of biomedical foams. Part one discusses the fundamentals of biomedical foams such as properties, structure and materials. Part two reviews tissue engineering applications of biomedical foams. CONTENTS

Part 1 Fundamentals of biomedical foams: Properties of biomedical foams; Biomedical foam pore structure; Polymeric biomedical foams; Glass biomedical foams; Composite biomedical foams. Part 2 Tissue engineering applications of biomedical foams: Injectable biomedical foams for bone regeneration; Biomedical glass and glass-ceramics foam-like scaffolds for bone tissue restoration; Polylactic acid (PLA) biomedical foams for tissue engineering; Biomedical foam scaffolds for nerve regeneration; Development of hydrogel biomedical foam scaffolds for tissue repair; Titanium biomedical foams for tissue attachment; Biodegradable biomedical foam scaffolds.

390 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 696 8 E-ISBN: 978 0 85709 703 3 Approx. £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9780857096968

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Applications NEW Novel biomaterials for bone regeneration

NEW Biomaterials for cancer therapeutics

NEW Nanomaterials in tissue engineering

Novel techniques and applications

Diagnosis, prevention and therapy

Edited by P Dubruel and S V Vlierberghe, University of Ghent, Belgium

Edited by K Park, Purdue University, USA

Fabrication and applications

Woodhead Publishing Series in Biomaterials No. 75

Biomaterials for bone regeneration is a large and important area of research for biomaterials scientists and engineers. This field continues to benefit from many technological developments and will continue to be a vital area of research for scientists. This book will provide readers with a comprehensive publication covering novel materials, techniques and applications of biomaterials for bone regeneration. The first section of this book provides readers with vital information on the various types of materials used in this arena. Chapters in part two discuss processing, modification and evaluation techniques of biomaterials. The final section of the book will look at cellular approaches and stimulation of biomaterials for bone regeneration. CONTENTS

Part 1 Materials for bone regeneration: Calcium phosphate cements for bone regeneration; Injectable calcium phosphate cements for bone repair; Hydrogels for bone regeneration; Biopolymer and synthetic polymer composites for bone regeneration; Polymeric scaffolds for bone regeneration. Part 2 Processing, surface modification and evaluation of biomaterials for bone regeneration: Rapid prototyping techniques for the development of porous polymeric scaffolds; Non-thermal plasma treatment for bone regeneration biomaterials; In vitro analysis of magnesium corrosion in orthopaedic biomaterials; Evaluation of mechanical properties of biomaterials for bone regeneration; Assessment of immunological properties of biomaterials for bone regeneration. Part 3 Cellular approaches and physical stimulation of biomaterials for bone regeneration applications: Nanocarriers for Controlled Drug Delivery; Gene transfer vectors (DNA vehicles) and their incorporation into biomaterials for bone repair; Stem cell technology for in vitro bone repair; Stem cell technology for in vivo bone repair; Potential of electromagnetic, ultrasound and laser stimulation for bone regeneration; Shape memory applications in mechanobiology and bone repair.

510 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 0 85709 804 7 E-ISBN: 978 0 85709 810 8 Approx. £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9780857098047

Woodhead Publishing Series in Biomaterials No. 66

Cancer can affect people of all ages, and approximately one in three people are estimated to be diagnosed with cancer during their lifetime. Numerous potential new therapeutics are being researched by many different institutions and biomaterials technology is now being developed to target, treat and prevent cancer. This unique book discusses the role and potential biomaterials have to treat this prevalent disease. The first part of the book discusses the fundamentals of biomaterials for cancer therapeutics. Chapters in part two discuss synthetic vaccines, proteins and polymers for cancer therapeutics. Part three focuses on theranosis and drug delivery systems whilst the final set of chapters look at biomaterial therapies and cancer cell interaction. CONTENTS

Part 1 Fundamentals of biomaterials for cancer therapeutics: Introduction to biomaterials for cancer therapeutics; Cancer cell biology; Targeted drug delivery for cancer therapy. Part 2 Synthetic vaccines, proteins, and polymers for cancer therapeutics: Chemical synthesis of carbohydrate-based vaccines against cancers; Generating functional mutant proteins to create bioactive anti-cancer biopharmaceuticals; Polymer therapeutics for treating cancer. Part 3 Theranosis and drug delivery systems for cancer therapeutics: Nanotechnology for cancer screening and diagnosis; Synergistically integrated nanomaterials for multimodal cancer cell imaging; Hybrid nanocrystal as a versatile platform for cancer theranostics; Embolisation devices from biomedical polymers for intra-arterial occlusion and drug delivery in the treatment of cancer; Small Interfering RNAs (siRNAs) as Cancer Therapeutics; Reverse Engineering of Low Temperature Sensitive Liposome (LTSL) for treating cancer; Gold nanoparticles (GNPs) as multi-functional materials for cancer treatment; Multifunctional nanosystems for cancer therapy. Part 4 Biomaterial therapeutics and cancer cell interaction: Biomaterial strategies to modulate cancer; 3D cancer tumour models for evaluating chemotherapeutic efficacy; Nanotopography of biomaterials for controlling cancer cell function.

528 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 664 7 E-ISBN: 978 0 85709 676 0 Approx. £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9780857096647

Edited by A K Gaharwar, Harvard Medical School and Massachusetts Institute of Technology, S Sant, University of Pittsburgh and Harvard Medical School, M J Hancock, Broad Institute and S A Hacking, Massachusetts General Hospital, USA Woodhead Publishing Series in Biomaterials No. 56

Nanomaterial technologies can be used to fabricate high-performance biomaterials with tailored physical, chemical, and biological properties. They are therefore an area of interest for emerging biomedical technologies such as scaffolding, tissue regeneration, and controlled drug delivery. Nanomaterials in tissue engineering explores the fabrication of a variety of nanomaterials and the use of these materials across a range of tissue engineering applications. Part one focuses on the fabrication of nanomaterials for tissue engineering applications. Part two highlights the application of nanomaterials in soft tissue engineering, while the use of nanomaterials in hard tissue engineering applications, including bone, dental and craniofacial tissue engineering is discussed in part three. CONTENTS

Biomedical nanomaterials in tissue engineering. Part 1 Fabrication of nanomaterials for tissue engineering applications: Synthesis of polymeric nanomaterials for biomedical applications; Engineering nanoporous biomaterials; Layer-by-layer self-assembly techniques for nanostructured devices in tissue engineering; Synthesis of carbon based nanomaterials for tissue engineering applications; Fabrication of nanofibrous scaffolds for tissue engineering applications; Fabrication of nanomaterials for growth factor delivery in tissue engineering. Part 2 Application of nanomaterials in soft tissue engineering: Nanomaterials for engineering vascularised tissues; Nanomaterials for cardiac tissue engineering; Nanomaterials for neural tissue engineering; Nanomaterials for cartilage tissue engineering; Biomaterials and nano-scale features for ligament regeneration. Part 3 Application of nanomaterials in hard tissue engineering: Nanomaterials for hard-soft tissue interfaces; Mineralization of nanomaterials for bone tissue engineering; Nanomaterials for dental and craniofacial tissue engineering.

488 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 596 1 E-ISBN: 978 0 85709 723 1 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9780857095961

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Applications NEW Standardisation in cell and tissue engineering

NEW Inhaler devices Fundamentals, design and drug delivery Edited by P Prokopovich, University of Cardiff, UK

Methods and protocols Edited by V Salih, Plymouth University Schools of Medicine and Dentistry, UK

Woodhead Publishing Series in Biomaterials No. 59

Woodhead Publishing Series in Biomaterials No. 58

The increased use of biodegradable synthetic or natural scaffolds combined with cells and/or biological molecules in the area of tissue engineering has led to the need for the development of ‘best practice’ methods to help ensure the creation of safe, high quality products. Standardisation in cell and tissue engineering introduces concepts and current practice in the field and aims to provide awareness of the importance of standardisation in this area while suggesting directions for further investigation. Part one provides an overview of methods for cell and tissue engineering. Part two begins with a chapter exploring the methods and protocols of standardisation in cell and tissue engineering before moving on to highlight issues of quality control in the area. CONTENTS

Part 1 Methods for cell and tissue engineering: Fundamentals of cell and matrix biology for tissue engineering; Threedimensional collagen biomatrix development and control; Two- and three-dimensional tissue culture bioprocessing methods for soft tissue engineering; Two- and threedimensional tissue culture methods for hard tissue engineering; Vascularisation of tissue-engineered constructs. Part 2 Standards and protocols in cell and tissue engineering: Standards in cell and tissue engineering; Principles of good laboratory practice (GLP) for in vitro cell culture applications; Quality control in cell and tissue engineering; Standardised chemical analysis and testing of biomaterials; Sterilisation procedures for tissue allografts; Commercial manufacture of cell therapies.

Given their direct impact on the health and quality of life for millions, inhalers represent a major turning point in the history of modern medicine. Inhaler devices: Fundamentals, design and drug delivery provides readers with an introduction to the fundamentals, with a comprehensive discussion of the history of inhalers as well as a discussion on current research and development. Part one discusses the fundamentals of inhaler devices, outlines drug formulations and provides an historical overview of the development of inhaler technology. Part two reviews recent developments in drug formulations and nanotechnology with applications to inhaler devices, and provides an exposition of recent innovations, emerging inhaler technology and possible future trends. CONTENTS

Part 1 Fundamentals and considerations of inhaler devices: Anatomy and pathophysiology of the respiratory system; History of inhaler devices; Tribology of inhaler devices and components; Novel coatings and biotechnology trends in inhaler devices; Microbial control and safety in inhalation devices. Part 2 Drug formulations for inhaler devices: Chitosan and inhalers: A bioadhesive polymer for pulmonary drug delivery; Polyelectrolyte assemblies for drug storage and delivery: Multilayers, nanocapsules, and multicapsules; Functionalized core-shell nanoparticles for medical applications.

192 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 496 4 E-ISBN: 978 0 85709 869 6 £120.00/US$200.00/€145.00 www.woodheadpublishing.com/9780857094964

272 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 419 3 E-ISBN: 978 0 85709 872 6 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9780857094193

Woodhead Publishing Online Woodhead Publishing Online is the only place the full collection of Woodhead e-books is available. Comprising over 1000 e-books and 17,000 chapters, the content provides an authoritative summary of key research, allowing readers to keep upto-date with major trends. The site offers extensive features and functionality including no DRM, no limit to the number of concurrent users and a range of innovative purchase options.

Features

Nanomedicine Technologies and applications Edited by T J Webster, Brown University, USA Woodhead Publishing Series in Biomaterials No. 49

Nanotechnology is at the forefront of advances in medicine. Nanomedicine: Technologies and applications provides an important review of this exciting technology and its growing range of applications. Part one discusses key materials and their properties, including nanocrystalline metals and alloys, nanoporous gold and hydroxyapatite coatings. Part two goes on to review nanomedicine for therapeutics and imaging. Nanomedicine for soft tissue engineering is discussed in part three, including organ regeneration, skin grafts, nanotubes and self-assembled nanomaterials. Finally, nanomedicine for bone and cartilage tissue engineering is the focus of part four, with electrically active biocomposites for smart scaffolds investigated alongside cartilage and bone tissue engineering, regeneration and replacement. CONTENTS

Part 1 Materials, properties and considerations: Introduction to nanomedicine; Trends in nanomedicine; Biomedical nanocrystalline metals and alloys: Structure, properties and applications; Nanoporous gold for biomedical applications: Structure, properties and applications; Hydroxyapatite (HA) coatings for biomaterials. Part 2 Nanomedicine for therapeutics and imaging: Calcium-phosphate coated magnetic nanoparticles for treating bone diseases; Orthopaedic carbon nanotube biosensors for controlled drug delivery; Nanostructured selenium anti-cancer coatings for orthopaedic applications; Nanoparticulate targeted drug delivery using peptides and proteins; Nanotechnology for DNA and RNA delivery; Gold nanoshells for imaging and photothermal ablation of cancer; Microfluidics for testing and delivering nanomedicine; Zinc oxide nanowires for biomedical sensing and analysis. Part 3 Nanomedicine for soft tissue engineering: Nanotechnology and tissue engineered organ regeneration; Rapid fabrication of biomimetic nanofiber-enabled skin grafts; Nanotubes for tissue engineering; Self-assembled nanomaterials for tissue engineering applications. Part 4 Nanomedicine for bone and cartilage tissue engineering: Electrically active biocomposites for smart scaffolds for bone tissue engineering; Nanotechnology for cartilage and bone regeneration; Nanostructured materials for bone tissue replacement; Nanocomposites for cartilage regeneration.

704 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 0 85709 233 5 E-ISBN: 978 0 85709 644 9 £182.50/US$300.00/€220.00 www.woodheadpublishing.com/9780857092335

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Applications Biomaterials in plastic surgery

Biomaterials for spinal surgery

Advanced wound repair therapies

Breast implants

Edited by L Ambrosio, Università di Napoli Federico II, Italy and E Tanner, University of Glasgow, UK

Edited by D Farrar, Smith and Nephew, UK

Edited by W Peters, University of Toronto, Canada, H Brandon, K L Jerina, Washington University in St Louis, C Wolf, formerly Washington University in St Louis and V L Young, BodyAesthetic Plastic Surgery and Skincare Center, USA Woodhead Publishing Series in Biomaterials No. 42 ‘For the academic surgeon who desires a grouping of articles specifically related to breast implants in one place, this book fills the bill.’

Doody’s book reviews Biomaterials in plastic surgery reviews the history, materials and safety issues associated with breast implants. Beginning with an introduction to the history of biomaterials used for breast augmentation, the book goes on to discuss development issues. It then discusses the chemistry and physical properties of biomedical silicones before reviewing cohesive gel and polyurethane foam implants. The book concludes by analysing the epidemiological evidence on the safety issues relating to breast implants, followed by a review of retrieval and analysis of breast implants emphasizing strength, durability and failure mechanisms. CONTENTS

The history of biomaterials used for breast augmentation; The development of breast implants; The chemistry and physical properties of biomedical silicones; Cohesive gel breast implants; Polyurethane foam breast implants; The safety of breast implants: Recent epidemiological studies; Retrieval and analysis of breast implants emphasizing strength, durability, and failure mechanisms.

240 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 799 0 E-ISBN: 978 0 85709 641 8 £125.00/US$205.00/€150.00 www.woodheadpublishing.com/9781845697990

Woodhead Publishing Series in Biomaterials No. 34

Woodhead Publishing Series in Biomaterials No. 39 ‘This is a good reference on biomaterials. It will be of most interest to materials engineers, bioengineers and spine surgeons. It is well written and provides an extensive list of references.’

Doody’s Book Reviews There have been important developments in materials and therapies for the treatment of spinal conditions. Biomaterials for spinal surgery summarises this research and how it is being applied for the benefit of patients. After an introduction to the subject, part one reviews fundamental issues such as spinal conditions and their pathologies, spinal loads, modelling and osteobiologic agents in spinal surgery. Part two discusses the use of bone substitutes and artificial intervertebral discs whilst part three covers topics such as the use of injectable biomaterials like calcium phosphate for vertebroplasty and kyphoplasty as well as scoliosis implants. The final part of the book summarises developments in regenerative therapies such as the use of stem cells for intervertebral disc regeneration. CONTENTS

Introduction to biomaterials for spinal surgery. Part 1 Fundamentals of biomaterials for spinal surgery: An overview of the challenges of bringing a medical device for the spine to the market; Introduction to spinal pathologies and clinical problems of the spine; Forces on the spine; Finite element modelling of the spine; Osteobiologic agents in spine surgery. Part 2 Spinal fusion and intervertebral discs: Spine fusion: Cages, plates and bone substitutes; Artificial intervertebral discs; Biological response to artificial discs. Part 3 Vertobroplasty and scoliosis surgery: The use of polymethyl methacrylate (PMMA) in neurosurgery; Optimising the properties of injectable materials for vertebraplasty and kyphoplasty; Injectable calcium phosphates for vertebral augmentation; Composite injectable materials for vertebroplasty; Scoliosis implants: Surgical requirements; Shape memory, superelastic and low Young’s modulus alloys. Part 4 Regenerative medicine in the spine: Cellbased tissue engineering approaches for disc regeneration; Angiogenesis control in spine regeneration; Stem cells for disc regeneration; Nucleus regeneration; In vivo models of regenerative medicine in the spine.

652 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 986 4 E-ISBN: 978 0 85709 619 7 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781845699864

‘The book comprises a nice overview of various kinds of therapies and a sufficiently extensive discussion of important (future) materials and treatments.’

Birgit Stubbe, Biomaterials Network CONTENTS

Part 1 Introduction to chronic wounds: Dysfunctional wound healing in chronic wounds; The role of micro-organisms and biofilms in dysfunctional wound healing; Scarring and scarless wound healing; The discovery and development of new therapeutic treatments for the improvement of scarring; Monitoring chronic wounds and determining treatment. Part 2 Biomaterial therapies for chronic wounds: Functional requirements of wound repair biomaterials; Tissuebiomaterial interaction; Polymeric materials for chronic wound and burn dressings; Dry wound healing concept using spray-on dressing for chronic wounds; Assessing the effectiveness of antimicrobial wound dressings in vitro; Adhesives and interfacial phenomena in wound healing; Wound healing studies and interfacial phenomena: Use and relevance of the corneal model; Sulphonated biomaterials as glycosaminoglycan mimics in wound healing. Part 3 Molecular therapies for chronic wounds: Drug delivery dressings; Molecular and gene therapies for wound repair; Antimicrobial dressings; Avotermin: Emerging evidence of efficacy for the improvement of scarring. Part 4 Biologically-derived and cell-based therapies for chronic wounds: Engineered tissues for wound repair; Commercialisation of engineered tissue products; Biologically derived scaffolds; Stem cell therapies for wound repair. Part 5 Physical stimulation therapies for chronic wounds: Electrical stimulation for wound healing; Negative pressure wound therapy; Debridement methods of non-viable tissue in wounds.

672 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 700 6 E-ISBN: 978 0 85709 330 1 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9781845697006

Biomaterials for artificial organs Edited by M Lysaght and T J Webster, Brown University, USA Woodhead Publishing Series in Biomaterials No. 29 ‘Undoubtedly a useful resource, it would be well placed in the biotechnology section of any university library.’

Materials World CONTENTS

Part 1 Commodity biomaterials: Membranes for oxygenators and plasmafilters: Titanium and cobalt-chromium alloys for hips and knees; Polymeric joint bearing surfaces for total joint replacements; Biomaterials for pacemakers, defibrillators and neurostimulators; Mechanical and bioprosthetic valves. Part 2 Advanced and next generation biomaterials: Small intestinal submucosa and other decullarized matrix biomaterials for tissue repair; New ceramics and composites for joint replacement surgery; Biomaterials for improving the blood and tissue compatibility of Total Artificial Hearts (TAH) and Ventricular Assist Devices (VAD); Nanostructured biomaterials for artificial tissues and organs; Matrices for tissue engineering and regenerative medicine.

320 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 653 5 E-ISBN: 978 0 85709 084 3 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9781845696535

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Applications Regenerative medicine and biomaterials for the repair of connective tissues

Drug-device combination products Delivery technologies and applications

Edited by C Archer and J Ralphs, Cardiff University, UK

Edited by A Lewis, Biocompatibles UK Ltd, UK

Woodhead Publishing Series in Biomaterials No. 24 CONTENTS

Woodhead Publishing Series in Biomaterials No. 22 CONTENTS

Structure and regenerative capacity of synovial joint tissues; The myofibroblast in connective tissue repair and regeneration. Part 1 Cartilage repair and regeneration: Structure of articular cartilage; Measuring the biomechanical properties of cartilage cells; Understanding tissue response to cartilage injury; Understanding osteoarthritis and other cartilage diseases; Using animal models of cartilage repair to screen new clinical techniques; Cartilage tissue repair: Autologous osteochondral mosaicplasty; Cartilage tissue repair: Autologous chondrocyte implantation; Cell sheet technologies for cartilage repair; Cell therapies for articular cartilage repair: Chondrocytes and mesenchymal stem cells; Scaffolds for musculoskeletal tissue engineering; Outcome measures of articular cartilage repair. Part 2 Repair of tendons and ligaments: The structure of tendons and ligaments; Tendon biomechanics; Tendon injury and repair mechanisms; Tissue engineering for ligament and tendon repair; Cell-based therapies for the repair and regeneration of tendons and ligaments; Scaffolds for tendon and ligament tissue engineering.

504 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 417 3 E-ISBN: 978 1 84569 779 2 £165.00/US$270.00/€200.00 www.woodheadpublishing.com/9781845694173

Biomaterials and regenerative medicine in ophthalmology

Part 1 Overview: Drug-device combination products; Enabling drug delivery from combination products; Nanomedical drugdevice combination products. Part 2 Areas of application: Catheter-based drug-device combination products: An overview; Catheter-based drug-device combination products: The anti-infective 5-fluorouracil-coated central venous catheter; Future outlook for drug eluting stents (DES); Drug eluting beads (DEB) in the treatment of liver cancer; Antibiotic-loaded bone cements; Glass-ionomer cements as drug-device combination products; Bone graft substitutes as drug-device combination products; Antibacterial releasing dental restorative materials; Collagen-based dressings as therapeutic agents for wound healing; Drug-device combination products for occular applications. Part 3 Development of drug-device combination products: Safety and efficacy issues in designing drug-device combination products: The case of drug eluting stents (DES); Preclinical testing of drug-device combination products; Sterilisation of drug-device combination products; Innovation and patent issues in the development of drug-device combination products: The case of drug eluting stents (DES); Regulation of drug-device combination products in Europe; (28a) Regulation of drug-device combination products in the USA.

560 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 470 8 E-ISBN: 978 1 84569 748 8 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9781845694708

Materials science for dentistry Ninth edition

Edited by T V Chirila, Queensland Eye Institute, Australia

B W Darvell, formerly University of Hong Kong, Hong Kong and now Professor in Dental Materials Science at Kuwait University, Kuwait.

Woodhead Publishing Series in Biomaterials No. 23 CONTENTS

Woodhead Publishing Series in Biomaterials No. 19

An introduction to ophthalmic biomaterials and their application through tissue engineering and regenerative medicine. Part 1 Applications in the anterior segment: Advances in intraocular lens development; Opacification and degradation of implanted intraocular lenses; Synthetic corneal implants; Corneal tissue engineering versus synthetic artificial corneas; Tissue engineering of human cornea; Engineering the corneal epithelial cell response to materials; Reconstruction of the ocular surface using biomaterials; Tissue engineering of the lens: Fundamentals; Bioinspired biomaterials for soft contact lenses; Contact lenses: The search for superior oxygen permeability; Extended wear contact lenses. Part 2 Applications in the posterior segment: Designing hydrogels as vitreous substitutes in ophthalmic surgery; Retinal repair and regeneration; Development of tissue-engineered membranes for the culture and transplantation of retinal pigment epithelial cells. Part 3 Other applications: Hydrogel sealants for wound repair in ophthalmic surgery; Orbital enucleation implants: Biomaterials and design; Selected polymeric materials for orbital reconstruction; Physicochemical properties of hydrogels for use in ophthalmology.

560 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 443 2 E-ISBN: 978 1 84569 743 3 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9781845694432

‘… a truly excellent book that covers the topic in greater depth and with greater authority than other dental texts.’

Professor Timothy F. Watson, King’s College London, UK ‘There is no doubt – it is the best in the field.’

Professor Nikhil K. Sarkar, Louisiana State University, USA 688 pages 280 X 210mm (8 x 11) paperback 2009 ISBN: 978 1 84569 529 3 E-ISBN: 978 1 84569 667 2 £52.50/US$85.00/€65.00 www.woodheadpublishing.com/9781845695293

Dental biomaterials Imaging, testing and modelling Edited by R V Curtis and T F Watson, King’s College London, UK

Bone repair biomaterials Edited by Principal editor J A Planell, Institute for Bioengineering of Catalonia (IBEC), Spain, Section editors S M Best, University of Cambridge, UK, D Lacroix, Institute for Bioengineering of Catalonia (IBEC), Spain and A Merolli, The Catholic University in Rome, Italy Woodhead Publishing Series in Biomaterials No. 20 ‘The book is beautifully referenced. Certain chapters are recommended for all orthopaedic surgeons... For a new researcher it is an invaluable introduction from start to finish.’

Journal of Bone and Joint Surgery CONTENTS

Part 1 Introduction: Challenges of bone repair; Bone anatomy, physiology and adaptation to mechanical loading; Bone repair and regeneration; Biomechanical aspects of bone repair. Part 2 Biomaterials: Properties and characterisation of bone repair materials; Metals as bone repair materials; Ceramics as bone repair materials; Polymers for bone repair; Composite biomaterials for bone repair; Cements as bone repair materials; Bioactive polymer coatings to improve bone repair; Long-term performance and failure of orthopaedic devices. Part 3 Clinical applications: Using bone repair materials in orthopaedic surgery; Bone tissue engineering; Retrieval and analysis of orthopaedic implants; Ethical issues in bone repair and bone tissue engineering.

496 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 385 5 E-ISBN: 978 1 84569 661 0 £165.00/US$270.00/€200.00 www.woodheadpublishing.com/9781845693855

Orthopaedic bone cements Edited by S Deb, King’s College London, UK Woodhead Publishing Series in Biomaterials No. 14 CONTENTS

Part 1 Bone cements in medicine: Bone disease; Hip replacements; Knee replacements; Vertebroplasty and kyphoplasty; Antibiotic-impregnated polymethylmethacrylate (PMMA) spacers in hip surgery; Commercial aspects and delivery systems of bone cements; Wear particles and osteolysis. Part 2 Materials: Acrylic bone cement: Genesis and evolution; Poly(methylmethacrylate) bone cement: Chemical composition and chemistry; Calcium phosphate bone cements. Part 3 Properties of bone cements: Mechanical properties of bone cements; Fracture toughness and fatigue characteristics of bone cements; Dynamic creep in bone cements. Part 4 Enhancing the properties of bone cements; Antibiotic-loaded bone cements; Modifications of bone cements; Design of bioactive bone cement based on organic-inorganic hybrids; Clinical aspects of calcium phosphate bone cements.

424 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 376 3 E-ISBN: 978 1 84569 517 0 £165.00/US$270.00/€200.00 www.woodheadpublishing.com/9781845693763

Woodhead Publishing Series in Biomaterials No. 10

528 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 296 4 E-ISBN: 978 1 84569 424 1 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781845692964

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27


Clinical techniques Biomaterials and tissue engineering in urology Edited by J Denstedt, University of Western Ontario, Canada and A Atala, Wake Forest Institute for Regenerative Medicine, USA Woodhead Publishing Series in Biomaterials No. 18 CONTENTS

Part 1 Fundamentals: Introduction to biofilms in urology: In vivo models for ureteral stents; Models for the assessment of biofilm and encrustation formation on urological materials. Part 2 Materials and design of urological devices: Ureteral stents: Design and materials; Metal stents in the upper urinary tract; Coated ureteral stents; Proteus mirabilis biofilm formation and catheter design; Selflubricating catheter materials; Temporary urethral stents; Penile implants. Part 3 Urological tissue engineering: Artificial biomaterials for urological tissue engineering; Natural biomaterials for urological tissue engineering; Nanotechnology and urological tissue engineering; Assessing the performance of tissue-engineered urological implants; Regenerative pharmacology and bladder regeneration; Autologous cell sources for urological applications; Embryonic stem cells, nuclear transfer, and parthenogenesisderived stem cells for urological reconstruction; Amniotic fluid and placental stem cells as a source for urological regenerative medicine; The use of adipose progenitor cells in urology; Regenerative medicine of the urinary sphincter via an endoscopic approach; Regenerative medicine of the urinary sphincter via direct injection; Regenerative medicine for the urethra; Penile reconstruction; Tissue engineering in reproductive medicine; Regenerative medicine of the kidney; Stem cells and kidney regeneration; Techniques for engineering bladder tissue.

592 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 402 9 E-ISBN: 978 1 84569 637 5 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781845694029

Biomaterials for treating skin loss Edited by D P Orgill, Brigham and Women’s Hospital and C Blanco, Joseph M. Still Research Foundation, USA Woodhead Publishing Series in Biomaterials No. 17 CONTENTS

CLINICAL TECHNIQUES

NEW The hip resurfacing handbook

NEW Perspectives in total hip arthroplasty Advances in biomaterials and their tribological interactions Edited by S Affatato, Rizzoli Orthopaedic Institute, Italy Due to an ageing population in the western world, total hip arthroplasty (THA), is the most commonly performed orthopaedic procedure. Arthroplasty comes from two Greek words, arthros or joint and plassein, to form or shape. THA is performed to replace or reconstruct a joint with an artificial joint (prosthesis). Hip prostheses may be made of metal, ceramic, plastic, or various combinations of these materials. Chapters in the first part of the book cover techniques from innovative surgeons, designs from multinational manufacturers as well as information on improvements in technologies and biomaterials. The second part of the book discusses the tribology of all the major materials used in total hip arthroplasty, allowing readers to understand the wear of these load bearing surfaces which is one of the major causes in the failure of hip prostheses. CONTENTS

Part 1 Advances in total hip arthroplasty (THA) techniques: The history of total hip arthroplasly (THA); The history of Biomaterials used in total hip arthroplasty (THA); Historical techniques and designs in total hip arthroplasty (THA); Contemporary designs in total hip arthroplasty (THA); Fixation of total hip arthroplsaty (THA) components; Recent developments and future trends in total hip arthroplasty (THA). Part 2 Tribology of biomaterials for total hip arthroplasty (THA): Tribology of the modern Biomaterials used in total hip arthroplasty (THA); Tribology of Polyethylene in total hip arthroplasty (THA); Tribology of Metal in total hip arthroplasty (THA); Tribology of Ceramic bearings in total hip arthroplasty (THA); Tribology of hybrid hard bearings in total hip arthroplasty (THA).

390 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 1 78242 031 6 E-ISBN: 978 1 78242 039 2 Approx. £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9781782420316

Part 1 Introduction: Development of skin substitutes; Skin replacement products and markets; Biomechanics of skin; The pathophysiologic basis for wound healing and cutaneous regeneration; Skin grafts; Understanding the cellular basis of skin growth; The regulatory approval process for biomaterials for treating skin loss. Part 2 Epidermal and dermal replacement technologies: Enhancing skin epidermal stability; Human-derived acellular matrices for dermal replacement; Lyophilized xenogenic products for skin replacement. Part 3 Combined dermis and epidermal replacement: Cultured skin substitutes; The use of keratinocytes in combination with a dermal replacement to treat skin loss; Principles of skin regeneration; Summary: Biomaterials for treating skin loss.

256 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 363 3 E-ISBN: 978 1 84569 554 5 £132.50/US$220.00/€160.00 www.woodheadpublishing.com/9781845693633

A practical guide to the use and management of modern hip resurfacings Edited by K De Smet, ANCA Clinic, Belgium, P Campbell, UCLA, USA and C Van Der Straeten, Consultant, Belgium Woodhead Publishing Series in Biomaterials No. 47 ‘For the orthopaedic surgeon who wishes to consider undertaking hip resurfacing as part of a clinical workload, they would definitely benefit from the wealth of experience and the comparative data from the large range of designs available described in this book.’

R J Minns PhD, SCOPE, IPEM Surface arthroplasty (surface replacement) of the hip with metal-on-metal bearings is one of the fastest growing areas within the field of joint surgery. Chapters in part one provide readers with information on a wide range of hip resurfacing designs. Part two focuses on clinical follow-up to hip resurfacing. Part three discusses a variety of operative techniques, and the final section provides readers with case studies and conclusions. CONTENTS

Part 1 Hip resurfacing designs: The ACCIS hip resurfacing prosthesis; The ADEPT® hip resurfacing prosthesis; The DePuy Articular Surface Replacement (ASR) hip resurfacing prosthesis; The Birmingham Hip Resurfacing (BHR) prosthesis; The Conserve® Plus hip resurfacing prosthesis; The CormetTM hip resurfacing prosthesis; The Durom hip resurfacing prosthesis; The ESKA hip resurfacing prosthesis; The ICON hip resurfacing prosthesis; The MRS Modular Hip Resurfacing prosthesis; The MIHR International® hip resurfacing prosthesis; The MITCH hip resurfacing prosthesis; The BIOMET RECAP hip resurfacing prosthesis; The ROMAX® hip resurfacing system; The Tornier DynaMoM hip resurfacing prosthesis; Design issues and comparison of hip resurfacing prostheses. Part 2 Clinical follow-up: Clinical follow-up of the hip resurfacing patient; Acoustic phenomena in hip resurfacing; Rehabilitation of patients after hip resurfacing; The use of radiography to evaluate hip resurfacing; The use of bone scintigraphy to evaluate hip resurfacing; The use of ultrasound to evaluate hip resurfacing; The use of Computerized Tomography (CT) to evaluate hip resurfacing; The use of magnetic resonance imaging (MRI) to evaluate hip resurfacing; The use of Positron Emission Tomography (PET) to evaluate hip resurfacing; The use of dual energy x-ray absorptiometry (DEXA) to evaluate hip resurfacing; The use of metal ion level measurements to evaluate hip resurfacing; The practical application of metal ion level measurement in evaluating hip resurfacing. Part 3 Operative techniques: Comparing surgical techniques in hip resurfacing; Surgical technique in hip resurfacing: The modified posterior approach; Surgical technique in hip resurfacing: The anterior approach; Tips and tricks for successful hip resurfacing; Surgical instruments in hip resurfacing; Anaesthesia in hip resurfacing; Revision surgery for failed hip resurfacing. Part 4 Failure modes in hip resurfacing; Retrieval studies showing failure modes in hip resurfacing; Case studies of femoral neck fractures in hip resurfacing; Case studies of femoral loosening and femoral head collapse in hip resurfacing; Case studies of acetabular loosening in hip resurfacing; Case studies of acetabular malposition and high wear in hip resurfacing; Case studies of suspected metal allergy in hip resurfacing. Part 5 General issues: The patient experience of hip resurfacing; Comparing hip resurfacing arthroplasty (HRA) and total hip arthroplasty (THA); The current regulatory status of hip resurfacing arthroplasty (HRA); Web sites relating to hip resurfacing.

576 pages 279 x 216mm (8 x 11) hardback 2013 ISBN: 978 1 84569 948 2 E-ISBN: 978 0 85709 620 3 £225.00/US$370.00/€270.00 www.woodheadpublishing.com/9781845699482

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Materials NEW Decontamination in hospitals and healthcare

NEW A practical approach to spinal trauma

Edited by J Walker, Public Health England, UK

Edited by H N Bajaj and S Katoch, Max Healthcare Hospital, India

Woodhead Publishing Series in Biomaterials No. 62

Effective infection control and decontamination in the healthcare sector is vital to public health. This unique book discusses decontamination practices and the development of technologies for cleaning and control of infection. Part one considers the role of standards in decontamination and infection control in Europe. Part two focuses on decontamination practices in healthcare, particularly the role of nurses, issues of microbial biofilm in waterlines, control of waterborne microorganisms and gaseous decontamination technologies. It explores decontamination of prions, no-touch automated room disinfection systems and controlling the presence of microorganisms in hospitals. Part three discusses decontamination and sterilisation of surgical instruments and endoscopes. The choice framework for protocols for decontamination of surgical instruments and novel technologies for cleaning and detection of contamination are examined.

Woodhead Publishing Series in Biomaterials No. 69

The book deals with fractures of the spine and it details classification and the management of spinal injuries. Authors share their experiences and include useful tips and practical approach to spinal trauma. There is also a discussion on non-operative management. Ultimately the treating surgeon needs to decide, with the resources and facilities in mind, what is best for the patient. CONTENTS

Part 1 Terminology; Applied anatomy of the spinal cord; Setting goals; Is walking possible in paraplegia? Psycological support in spinal cord injury; Acute care in spinal cord injury; Problems unique to tetraplegia; Operative or non operative management? Select issues in chronic spinal cord injury. Part 2 Fractures of the cervical spine; Fractures of the cervico dorsal junction; Fractures of the thoracolumbar spine; Fractures of the sacrum; Fractures of the spine in ankylosing spondylitis; Osteoporotic fractures of the spine.

A Woodhead Publishing India title 150 pages 234 x 156mm (6 x 9) hardback Q4 2014 ISBN: 978 1 78242 066 8 E-ISBN: 978 1 78242 070 5 Approx. £80.00/US$130.00/€95.00 www.woodheadpublishing.com/9781782420668

CONTENTS

Part 1 Fundamentals of decontamination in hospitals and healthcare: The importance of decontamination in hospitals and healthcare; The history of decontamination in hospitals; The role of standards in decontamination; Infection control in Europe; Future trends in decontamination in hospitals and healthcare. Part 2 Decontamination practices in hospitals and healthcare: Decontamination in primary care: Dental and hospital perspectives; The role of the nursing in decontamination; Minimising microbial contamination in dental unit water systems and microbial control in dental hospitals; Control of waterborne microorganisms and reducing the threat from Legionella and Pseudomonas; The role of continuous microbial debulking in the hospital environment and its effect on reducing HCAIs; Provision and control of water for healthcare purposes; Use of gaseous decontamination technologies for wards and isolation rooms in hospitals and healthcare settings; Biocides and Decontamination agents including sporicides for decontamination in hospitals; Decontamination of prions; Cleaning and decontamination of the healthcare environment; The role of protective clothing in healthcare and its decontamination; A guide to no-touch automated room disinfection systems; New technologies to control the presence of microorganisms in hospitals; Testing strategies and international standards for disinfectants. Part 3 Decontamination of surgical instruments and endoscopes: An overview of current decontamination practices of surgical instruments and medical devices; An overview of choice framework for policies and protocols for decontamination of surgical instruments; New technologies for the decontamination of surgical instruments and subsequent detection of protein (EFSCAN); Efficacy of current and novel cleaning technologies (ID Box) for assessing protein contamination on surgical instruments; Decontamination of flexible endoscopes; Sterilisation of flexible endoscopes.

640 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 657 9 E-ISBN: 978 0 85709 669 2 Approx. £190.00/US$315.00/€230.00 www.woodheadpublishing.com/9780857096579

Preprosthetic and maxillofacial surgery Biomaterials, bone grafting and tissue engineering Edited by J Ferri, Roger Salengro Hospital, France and E Hunziker, University of Bern, Switzerland Woodhead Publishing Series in Biomaterials No. 32 CONTENTS

Bone tissue engineering. Part 1 Bone reconstruction in implantology and reconstructive preprosthetic surgery: Fundamentals of bone grafting in implantology; Cranial bone grafting in maxillary preprosthetic surgery; Maxillary sinus grafting for implant insertion; Symphyseal and alveolar reconstruction in preprosthetic surgery; Mandible corpus reconstruction for implant insertion: The available techniques; Alveolar bi-directional distraction in preprosthetic surgery; Alveolar widening using distraction osteogenesis (DO) in maxillofacial surgery; Bone grafting and Le fort 1 osteotomy in cases of major atrophy of the maxilla. Part 2 Reconstruction in particular situations: Applications of biomaterials in alveolar and maxillofacial bone reconstruction; Implants in congenital missing teeth; Maxillo-mandibular amputations and implants rehabilitation; Alveolar reconstruction in cleft for implant rehabilitation; Bone reconstruction in irradiated situations; Periodontal surgery related to alveolar bone reconstruction for implant insertion. Part 3 Tissue engineering: Mucosal and gingival tissue engineering; Osteoinductivization of dental implants and bone-defect-filling materials; Tissue engineering and endodontics; Tooth regeneration: Current status.

400 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 589 7 E-ISBN: 978 0 85709 242 7 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781845695897

MATERIALS NEW Bone substitute biomaterials Edited by K Mallick, University of Warwick, UK Woodhead Publishing Series in Biomaterials No. 78

Bone substitute biomaterials are a fundamental part of the biomaterials and biomedical sector and this area has benefitted from many recent technological developments. Recent research has particularly focussed on minimising failure rates and the need for further surgery, which can be achieved in particular through osseointegration and regeneration. The first section of this book provides readers with the principles of bone substitute biomaterials whilst the final section reviews biomaterials for bone regeneration. CONTENTS

Bone mechanics. Part 1 Properties of bone substitutes biomaterials in medicine: Composite materials for bone repair; Zirconia toughened composites for hard tissue replacements; Ceramic Foam; Titanium foam for replacing bone; Bioresorbable bone graft substitutes. Part 2 Biomaterials and implants: Bone substitutes based on biomineralization; Ceramics for skeletal bone regeneration; Osteoinductivization of dental implants and bone-defectfilling materials; Cartilage grafts for bone regeneration; Marine organisms for bone repair; Chitosan for bone repair.

390 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 0 85709 497 1 E-ISBN: 978 0 85709 903 7 Approx. £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9780857094971

NEW Regulatory affairs for biomaterials and medical devices Edited by S Amato and B Ezzell, Northeastern University, USA Woodhead Publishing Series in Biomaterials No. 79

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focuses on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. CONTENTS

Historical overview and current situation; Technical aspects of biomaterial commercialization; Regulatory strategies for USA; Clinical development and endpoint strategies; Supply Chain Risk Management; Approval of devices and biomaterials; Good manufacturing practice; Vigilance procedures/post market surveillance; Regulatory Strategies in Asia; Continuing evolution of market access paradigms from a health policy perspective.

300 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 0 85709 542 8 E-ISBN: 978 0 85709 920 4 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9780857095428

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29


Materials NEW Semiconducting silicon nanowires for biomedical applications Edited by J L Coffer, Texas Christian University, USA Woodhead Publishing Series in Biomaterials No. 73

The unique fundamental physico-chemical properties of semiconductor silicon nanowires provide a diverse toolbox from which scientists are tackling significant problems in human health at the nanoscale. Biological systems at both the in vitro and in vivo levels are being investigated, as is the fabrication, surface chemistry, and electronic properties of such materials. This book seeks to address the most critical range of issues emerging in this important field and its applications. Part one provides readers with a comprehensive overview of the field and fundamental technologies. Chapters in part two look at tissue engineering and selected drug delivery therapies. The final set of chapters address biomolecular detection and sensing applications of silicon nanowires. CONTENTS

Part 1 Introduction to silicon nanowires for biomedical applications: Overview of semiconducting silicon nanowires for biomedical applications; Growth and characterization of semiconducting silicon nanowires for biomedical applications; Surface modification of semiconducting silicon nanowires for biosensing applications; Biocompatibility of semiconducting silicon nanowires. Part 2 Silicon nanowires for tissue engineering and delivery applications: Functional semiconducting silicon nanowires for cellular binding and internalization; Functional semiconducting silicon nanowires and their composites as orthopaedic tissue scaffolds; Mediated differentiation of stem cells by engineered semiconducting silicon nanowires; Silicon nanoneedles for drug delivery. Part 3 Silicon nanowires for detection and sensing: Semiconducting silicon nanowire array fabrication for high throughput screening in the biosciences; Neural cell pinning on surfaces by semiconducting silicon nanowire arrays; Semiconducting silicon nanowires and nanowire composites for biosensing and therapy; Probe-free semiconducting silicon nanowire platforms for biosensing.

390 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 766 8 E-ISBN: 978 0 85709 771 2 Approx. £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9780857097668

NEW Porous silicon for biomedical applications

NEW Precious metals for biomedical applications

Edited by H A Santos, University of Helsinki, Finland

Edited by N Baltzer and T Copponnex, Cendres+Métaux, Switzerland

Woodhead Publishing Series in Biomaterials No. 68

Woodhead Publishing Series in Biomaterials No. 77

Porous silicon is rapidly attracting increasing interest in the biomaterials community. This nanostructured and biodegradable material has a range of properties, making it ideal for drug delivery and tissue engineering. In particular the pores of the material and surface chemistry can be manipulated to tune the rate of drug release from hours to months. Porous silicon for biomedical applications provides the reader with a comprehensive review of this emerging material. Chapters in part one focus on the fundamentals and properties of the material. Part two discusses applications in bio-imaging and sensing whilst the final set of chapters look at drug delivery, cancer therapy and tissue engineering applications.

Precious metals and semi-precious metals have been used in medicine for many years. The properties of these metals and their alloys make them suitable for an increasing number of medical applications. This book provides readers with a useful review of this group of materials’ unique properties and applications. The first part provides readers with the fundamentals of precious metals for biomedical applications before chapters in part two look at a wide range of applications of precious metals in medicine.

CONTENTS

Part 1 Fundamentals of porous silicon for biomedical applications: Porous silicon for biomedical applications: from conception to clinical use; Thermal stabilization of porous silicon for biomedical applications; Thermal properties of nanoporous silicon materials; Photochemical and non-thermal chemical modification of porous silicon for biomedical applications; Modifying porous silicon with self-assembled monolayers for biomedical applications; Protein-modified porous silicon films for biomedical applications; Biocompatibility of porous silicon for biomedical applications. Part 2 Porous silicon for bio-imaging and bio-sensing applications: Optical Properties of porous silicon materials for biomedical applications; In vivo imaging assessment of porous silicon; Radiolabeled porous silicon for bio-imaging applications; Desorption/ionization on porous silicon (DIOS) for metabolite bio-imaging; Porous silicon for bacteria detection; Nanoporous silicon biosensors for DNA sensing. Part 3 Porous silicon for drug delivery, cancer therapy and tissue engineering applications: Drug loading and characterization of porous silicon materials; Nanoporous silicon to enhance drug solubility; Multistage porous silicon for cancer therapy; Porous silicon for tumour targeting and imaging; Porous silicon - polymer composites for cell culture and tissue engineering applications; Porous silicon and related composites as functional tissue engineering scaffolds; Porous silicon scaffolds for stem cells growth and osteodifferentiation.

630 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 711 8 E-ISBN: 978 0 85709 715 6 Approx. £180.00/US$295.00/€215.00 www.woodheadpublishing.com/9780857097118

CONTENTS

Part 1 Fundamentals of precious metals for biomedical applications: Common alloys, properties and processing or precious metals for biomedical applications; Biocompatibility of precious metals for biomedical applications; Corrosion resistance of precious metals for biomedical applications; Optimizing the interface between gold nanoparticles (NPs) and the biological environment. Part 2 Biomedical applications of precious metals: Precious metal alloys for dental applications; Platinium group metals (PGMs) for permanent implantable electronic medical devices; Nanoporous gold for biomedical applications: Structure, properties and applications; Gold nanoparticles for bioimaging, drug delivery and therapeutics; Properties and applications of silver anti-bacterial coatings; Antibacterial silver doped bioactive glasses (BG) for tissue engineering applications.

330 pages 234 x 156mm (6 x 9) hardback Q2 2014 ISBN: 978 0 85709 434 6 E-ISBN: 978 0 85709 905 1 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9780857094346

Metals for biomedical devices Edited by M Niinomi, Tohoku University, Japan Woodhead Publishing Series in Biomaterials No. 25 CONTENTS

Part 1 General introduction: Overview of metals and biomedical applications; Metal selection for biomedical devices. Part 2 Mechanical behaviour, degradation and testing of metals for biomedical devices: Mechanical properties of metallic biomaterials; Corrosion of metallic biomaterials; Fatigue and failure of metallic biomaterials; Mechanical testing of metallic biomaterials; Tribology and tribo-corrosion testing and analysis of metallic biomaterials; Biocompatibility and fabrication of in situ bioceramic coating/titanium alloy biocomposites. Part 3 Processing metals for biomedical applications: Forging metals and alloys for biomedical applications; Surface treatment of metallic biomaterials; Coatings for metallic biomaterials; Biocompatible polymer assembly on metal surfaces; Sterilisation and cleaning of metallic biomaterials. Part 4 Specific applications of metals for biomedical devices: Orthopaedic applications of metallic biomaterials; New generation metallic biomaterials; Degradable metallic biomaterials for cardiovascular applications.

432 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 434 0 E-ISBN: 978 1 84569 924 6 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9781845694340

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Materials NEW New functional biomaterials for medicine and healthcare

NEW Biomaterials and medical tribology

NEW Biomimetic biomaterials

E P Ivanova, Swinburne University of Technology, K Bazaka, James Cook University and R J Crawford, Swinburne University of Technology, Australia

Research and development

Edited by A J Ruys, University of Sydney, Australia

Edited by J Paulo Davim, University of Aveiro, Portugal

Woodhead Publishing Series in Biomaterials No. 57

Woodhead Publishing Series in Biomaterials No. 67

Woodhead Publishing Series in Biomaterials No. 65

There has been a huge amount of recent research into developing and refining biomaterials for use in implants and other biomedical applications. This book provides a concise summary of this research. It begins with an overview of the different types of biomaterials, as well as their use in the design and assembly of medical implants. The book then reviews the main types of material used in biomaterials, including natural and synthetic polymers, metals, inert and bioactive ceramics. Individual chapters review particular types of biomaterial, their properties and applications. The book provides an ideal one-volume summary in this important field.

Medical tribology can be defined as the science of tribological phenomena in the human body, both those that naturally occur in the tissues or organs and those that arise after implantation of an artificial device, while biomaterials are inert substances designed to be incorporated into living systems. Biomaterials and medical tribology brings together a collection of high quality articles and case studies focussing on new research and developments in these two important fields. The book provides details of the different types of biomaterial available, including metals, polymers and composites, while chapters in the latter half offer an analysis of friction, wear, lubrication and other related issues in specific applications.

‘The only workable strategy in developing new biomaterials is to follow the best scientific practices in design and evaluation. Yet the vastness of the biomaterials literature and the general trend towards publishing only positive results makes it difficult to determine those best practices…This book is an antidote to many of these shortcomings by focusing on the state of the art in biomimetic biomaterials and their design.’

CONTENTS

Introduction to biomaterials and implantable device design; Natural polymer biomaterials: Advanced applications; Advanced synthetic polymer biomaterials derived from organic sources; Advanced synthetic and hybrid polymer biomaterials derived from inorganic and mixed organicinorganic sources; Metallic biomaterials: Types and advanced applications; Cytotoxicity and biocompatibility of metallic biomaterials; Bioinert ceramic biomaterials: Advanced applications; Advanced bioactive and biodegradable ceramic biomaterials.

304 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 1 78242 265 5 E-ISBN: 978 1 78242 266 2 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781782422655

Bioactive materials in medicine

CONTENTS

Nanoparticles for biomedical applications: Current status, trends and future challenges; Synergism effects during friction and fretting corrosion experiments – focusing on biomaterials used as orthopedic implants; Application of biomedical-grade titanium alloys in trabecular bone and artificial joints; Fatigue strengthening of an orthopedic Ti6Al4V alloy: What is the potential of a final shot peening process? Wear determination on retrieved metal-on-metal hip arthroplasty: An example of extreme wear; Natural articular joints: Model of lamellar-rollerbearing lubrication and the nature of the cartilage surface; Importance of bearing porosity in engineering and natural lubrication; Tribological characterization of human tooth enamel; Liposome-based carrier systems and devices used for pulmonary drug delivery.

490 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 017 1 E-ISBN: 978 0 85709 220 5 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9780857090171

Design and applications Edited by X Zhao, China Research Academy of Bioactive Molecules and Materials (RABMM) and University of Strathclyde, UK, J M Courtney, University of Strathclyde, UK and H Qian, Queen Mary University London, UK Woodhead Publishing Series in Biomaterials No. 33 CONTENTS

Introduction to bioactive materials in medicine. Part 1 Designing bioactive materials for use in medicine: Molecular design of bioactive materials with controlled bioactivity; Bioactive materials and nanotechnology; Bioactive materials and tissue engineering. Part 2 Applications of bioactive materials in medicine: Antibacterial bioactive materials; Bioactive materials in orthopaedics; Bioactive materials in the circulatory system; Bioactive materials in gene therapy; Bioactive materials in plastic surgery and body reconstruction; Bioactive materials in drug delivery systems.

288 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 624 5 E-ISBN: 978 0 85709 293 9 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781845696245

Biomedical composites Edited by L Ambrosio, National Research Council, Italy Woodhead Publishing Series in Biomaterials No. 21

648 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 436 4 E-ISBN: 978 1 84569 737 2 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781845694364

Natural-based polymers for biomedical applications Principal editor: R L Reis, Section editors: N M Neves, J F Mano, M E Gomes, A P Marques and H S Azevedo, University of Minho, Portugal Woodhead Publishing Series in Biomaterials No. 12

832 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 264 3 E-ISBN: 978 1 84569 481 4 £207.50/US$340.00/€250.00 www.woodheadpublishing.com/9781845692643

Structure and applications

From the Foreword by Professor Luke Hanley, University of Illinois at Chicago, USA A significant proportion of modern medical technology has been developed through biomimetics, which is biologically inspired by studying pre-existing functioning systems in nature. Typical biomimetically inspired biomaterials include nano-biomaterials, smart biomaterials, hybrid biomaterials, nano-biocomposites, hierarchically porous biomaterials and tissue scaffolds. This important book summarises key research in this important field. The first part of the book is devoted to the biomimetics of biomaterials themselves, while part two provides overviews and case studies of tissue engineering applications from a biomimetics perspective. CONTENTS

Part 1 Biomimetic biomaterials, structure and surfaces: Biomimetic materials in regenerative medicine; Biomimetic potential of chitin-based composite biomaterials of poriferan origin; Hierarchical structure, mechanical properties and fabrication of biomimetic biomaterials; Biomimetic coatings for biomaterial surfaces; Functional gradients in natural and biomimetic spinal disk structures. Part 2 Tissue engineering applications of biomimetic biomaterials: Biomimetic scaffolds for skin tissue and wound repair; Biomimetic scaffolds for stem cell based tissue engineering; Biomimetic bone regeneration; Biomimetic hydrogels as scaffolds for tissue engineering applications; Injectable biomimetic hydrogels for soft tissue repair.

344 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 416 2 E-ISBN: 978 0 85709 888 7 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9780857094162

Biomedical polymers Edited by M Jenkins, University of Birmingham, UK Woodhead Publishing Series in Biomaterials No. 7 ‘...this publication offers an unsurpassable opportunity to facilitate immersion in a rapidly expanding interdisciplinary area.’ ‘...a source of reference for scientists and, in general, all professionals involved in the development and use of this important group of biomaterials.’

Revista de Plásticos Modernos 236 pages 234 x 156mm (6 x 9) hardback 2007 ISBN: 978 1 84569 070 0 E-ISBN: 978 1 84569 364 0 £132.50/US$220.00/€160.00 www.woodheadpublishing.com/9781845690700

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31


Materials NEW Diamond-based materials for biomedical applications

Characterization of biomaterials

Wear of orthopaedic implants and artificial joints

Edited by R Narayan, University of North Carolina, USA

Edited by M Jaffe, New Jersey Institute of Technology, W Hammond, P Tolias, University of Medicine and Dentistry New Jersey and T Arinzeh, New Jersey Institute of Technology, USA

Woodhead Publishing Series in Biomaterials No. 55

Woodhead Publishing Series in Biomaterials No. 64

Carbon is light weight, strong, conductive and able to mimic natural materials within the body, making it ideal for many uses within biomedicine. Consequently a great deal of research and funding is being put into this interesting material with a view to increasing the variety of medical applications for which it is suitable. Diamond-based materials for biomedical applications presents readers with the fundamental principles and novel applications of this versatile material.

‘A brief, yet very well-written and useful overview, suitable for specialists as well as researchers new to the field.’

CONTENTS

Part 1 Introduction to diamond based materials for medical applications: Introduction to medical applications of diamond particles and surfaces; Functionalisation of diamond surfaces for medical applications; Biotribology and biological behaviour of nanocrystalline diamond (NCD) coatings for medical applications; Blood compatibility of diamond-like carbon (DLC) coatings. Part 2 Biomedical applications of diamond based materials: Nanostructured diamond coatings for orthopaedic applications; Ultrananocrystalline diamond (UNCD) films for ophthalmological applications; Ultrananocrystalline diamond (UNCD) for neural applications; Nanodiamonds for drug delivery systems; Diamond nucleation and seeding techniques for tissue regeneration; Diamond materials for microfluidic devices.

296 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 340 0 E-ISBN: 978 0 85709 351 6 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9780857093400

Shape memory alloys for biomedical applications Edited by T Yoneyama, Nihon University and S Miyazaki, University of Tsukuba, Japan Woodhead Publishing Series in Biomaterials No. 15 CONTENTS

Part 1 Materials: The shape memory effect and superelasticity in Ti-Ni alloys; Mechanical properties of shape memory alloys; Thermodynamics of the shape memory effect in Ti-Ni alloys; Alternative shape memory alloys; Fabrication of shape memory alloy parts; Response of Ti-Ni alloys for dental biomaterials to conditions in the mouth; Understanding, predicting and preventing failure of Ti-Ni shape memory alloys used in medical implants; Surface modification of Ti-Ni alloys for biomedical applications; Biocompatibility of Nitinol for biomedical applications. Part 2 Medical and dental devices: Self-expanding Nitinol stents for the treatment of vascular disease; Orthodontic devices using Ti-Ni shape memory alloys; Endodontic instruments for root canal treatment using Ti-Ni shape memory alloys; Regulation orthopaedic, dental, endovascular and other applications of Ti-Ni shape memory alloys.

Woodhead Publishing Series in Biomaterials No. 41

Dr. Aleksandr Ovsianikov, The Biomaterials Network. Biomaterials and medical devices must be rigorously tested in the laboratory before they may be implanted into test subjects. By ensuring that these test methods are both quick and efficient, an increased number of materials can be tested and working implants can be produced more rapidly. The development of such tests is therefore essential to biomedical advancement, and Characterization of biomaterials reviews the latest methods for defining properties and characterizing materials. Beginning with an introduction to microscopy techniques for analyzing the phase nature and morphology of biomaterials, Characterization of biomaterials goes on to discuss a wide array of techniques and various unique approaches to the problems faced in characterizing biomaterials, whilst also providing information on standards and methods for assessing the safety and biocompatibility of biomaterials.

This important book reviews the causes and prevention of implant wear. Part one discusses fundamental issues such as tissue response to wear, the anatomy and biomechanics of hips and knees as well as the materials and design issues they raise for hip, knee and other types of orthopaedic implant. Part two considers wear phenomena in a range of materials, including ultra-high molecular weight (UHMWPE), metal and ceramic joints. It also covers surgical and other factors influencing wear as well as ways of detecting, analysing and predicting implant wear and failure. CONTENTS

Part 1 Fundamentals of implant wear: Introduction to wear phenomenon of orthopaedic implants; Biology of implant wear; Biomechanics of the hip and knee: Implant wear; Anatomy of the hip and suitable prostheses; Anatomy of the knee and suitable prostheses; Orthopaedic implant materials and design; Materials used for hip and knee implants. Part 2 Wear phenomenon: The wear phenomenon of Ultra-High Molecular Weight Polyethylene (UHMWPE) joints; The wear phenomenon of metal joints; Wear phenomenon of ceramic joints; The influence of surgical techniques on implant wear; Factors contributing to orthopaedic implant wear; Diagnosis and surveillance of orthopaedic implants; Failure analysis of orthopaedic implants; Wear prediction of orthopaedic implants.

448 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 0 85709 128 4 E-ISBN: 978 0 85709 612 8 £155.00/US$255.00/€185.00 www.woodheadpublishing.com/9780857091284

CONTENTS

Microscopy techniques for analyzing the phase nature and morphology of biomaterials; Scattering techniques for structural analysis of biomaterials; Quantitative assays for measuring cell adhesion and motility in biomaterials; Assays for determining cell differentiation in biomaterials; Bioreactors for evaluating cell infiltration and tissue formation in biomaterials; Studying molecular-scale proteinsurface interactions in biomaterials; Assessing the mutagenic effects of biomaterials: Analyzing the cellular genome and abnormalities; Using microarrays to measure cellular changes induced by biomaterials; Standards and methods for assessing the safety and biocompatibility of biomaterials.

338 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 810 2 E-ISBN: 978 0 85709 368 4 £135.00/US$225.00/€160.00 www.woodheadpublishing.com/9781845698102

352 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 344 2 E-ISBN: 978 1 84569 524 8 £155.00/US$255.00/€185.00 www.woodheadpublishing.com/9781845693442

32

Edited by S Affatato, Istituto Ortopedico Rizzoli di Bologna, Italy

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Bioceramics and their clinical applications Edited by T Kokubo, Chubu University, Japan Woodhead Publishing Series in Biomaterials No. 9 CONTENTS

Part 1 Fundamentals of bioceramics: The structure and mechanical properties of bone; Fabrication processes for bioceramics; The microstructure of bioceramics and its analysis; The mechanical properties of bioceramics; The design of ceramics for joint replacement; Cellular response to bioactive ceramics; In vitro evaluation of bone bioactivity; Osteoconduction and its evaluation; Osteoinduction and its evaluation. Part 2 Types of bioceramics: Alumina ceramics; Zirconia ceramics; Bioactive glasses; Bioactive glass-ceramics; Calcium sulphate; Tricalcium phosphate-based ceramics; Hydroxyapatite; Tricalcium phosphate/hydroxyapatite biphasic ceramics; Si-substituted hydroxyapatite; Calcium phosphate cement; Calcium phosphate coatings; Titania-based materials; Ceramic-polymer composites; Dental ceramics; Dental glass-ceramics. Part 3 Clinical applications of bioceramics: Clinical application of bioactive glasses; Clinical application of bioactive glass-ceramics; Clinical application of hydroxyapatite; Clinical applications of alumina ceramics in joint replacement; Clinical applications of ceramics/ polyethylene in joint replacement; Tissue engineering using bioceramics.

784 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 204 9 E-ISBN: 978 1 84569 422 7 £200.00/US$330.00/€240.00 www.woodheadpublishing.com/9781845692049

Available / will be available on Woodhead Publishing Online


Medical textiles Coatings for biomedical applications

Biomedical hydrogels Biochemistry, manufacture and medical applications

MEDICAL TEXTILES

Edited by M Driver, Vertellus, UK

Edited by S Rimmer, University of Sheffield, UK

NEW Biotextiles as medical implants

Woodhead Publishing Series in Biomaterials No. 37

Woodhead Publishing Series in Biomaterials No. 31 CONTENTS

Edited by M W King, B S Gupta, North Carolina State University, USA and R Guidoin, Laval University Quebec, Canada

The biomaterials sector is rapidly expanding due to the increase in healthcare spending worldwide. Coatings and surface modification of biomaterials provides a means to improve the wear of joints, change the biological interaction between implant and host and combine the properties of various materials to improve device performance. The considerable interest in coatings for biomedical applications has resulted in a great deal of research in industry and academia. This book provides a comprehensive review of coatings and surface modification for biomedical applications, including background, theory, materials and applications. The clear structure and concise review of research provides a valuable resource to researchers in the field of biomedical coatings. CONTENTS

Part 1 Coating types and applications: Hydrophilic coatings for biomedical applications in and ex vivo; Mineral coatings for orthopaedic applications; Other commonlyused biomedical coatings: Pyrolytic carbon coatings; Electrochemical surface modifications of titanium and titanium alloys for biomedical applications; Surface preparation techniques for biomedical applications; Characterization of biomedical coatings. Part 2 Case studies: Coatings for cardiovascular devices: Coronary stents; Coatings for cardiovascular devices: Extracorporeal circuits; Surface coatings for ventricular assist devices; Orthopaedic coatings; Surface coatings in urology; Ophthalmic coatings.

376 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 568 2 E-ISBN: 978 0 85709 367 7 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9781845695682

Bioactive glasses Materials, properties and applications Edited by H O Ylänen, Tampere University of Technology, Finland Woodhead Publishing Series in Biomaterials No. 36 CONTENTS

Part 1 Materials and mechanical properties of bioactive glass: Melt-derived bioactive glasses; Surface modification of bioactive glasses; Cell interaction with bioactive glasses and ceramics; Regulatory aspects of bioactive glass. Part 2 Applications of bioactive glass: Bioactive glass and glass ceramic scaffolds for bone tissue engineering; Nanoscaled bioactive glass particles and nanofibres; Bioactive glasses containing composites for bone and musculoskeletal tissue engineering scaffolds; Use of bioactive glasses as bone substitutes in orthopaedics and traumatology; Bioactive glass S53P4 as a bone graft substitute in the treatment of osteomyelitis; Bioactive glass for maxillofacial and dental repair; Bioactive glass and biodegradable polymer composites; Bioactive glasses for wound healing.

288 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 768 6 E-ISBN: 978 0 85709 331 8 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781845697686

Part 1 Processing of hydrogels: Hydrogel swelling behaviour and its biomedical applications; Superabsorbent cellulosebased hydrogels for biomedical applications; Synthesis of hydrogels – control of structure and properties; Processing and fabrication technologies for biomedical hydrogels; Regulation of novel biomedical hydrogel products; Failure of hydrogel implants – mechanical properties. Part 2 Applications: Spinal disc implants using hydrogels; Hydrogels for intraocular lenses and other ophthalmic prostheses; Cartilage replacement implants using hydrogels; Imaging implants in situ.

288 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 590 3 E-ISBN: 978 0 85709 138 3 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781845695903

Injectable biomaterials Science and applications Edited by B Vernon, Arizona State University, USA Woodhead Publishing Series in Biomaterials No. 30 CONTENTS

Part 1 Materials and properties: Designing clinically useful substitutes for the extracellular matrix; Designing ceramics for injectable bone graft substitutes; Rheological properties of injectable biomaterials; Improving mechanical properties of injectable polymers and composites. Part 2 Clinical applications: Drug delivery applications of injectable biomaterials; Tissue engineering applications of injectable biomaterials; Vascular applications of injectable biomaterials; Orthopaedic applications of injectable biomaterials; Dental applications of injectable biomaterials; Injectable polymeric carriers for gene delivery systems. Part 3 Technologies and developments: Environmentally responsive injectable materials; Injectable nanotechnology; Injectable biodegradable materials; Troubleshooting and hurdles to development of biomaterials; Biocompatibility of injectable materials; Future applications of injectable biomaterials: The use of microgels as modular injectable scaffolds.

432 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 588 0 E-ISBN: 978 0 85709 137 6 £147.50/US$245.00/€175.00 www.woodheadpublishing.com/9781845695880

Hyaluronan Proceedings of an international meeting, September 2000, North East Wales Institute, UK Edited by J F Kennedy, University of Birmingham, G O Phillips, Phillips Hydrocolloid Research Ltd, P A Williams, North East Wales Institute of Higher Education, UK and Guest editor V C Hascall, Lerner Research Institute, USA 1152 pages 244 x 172mm (6 1/2 x 9 1/2) hardback 2002 ISBN: 978 1 85573 570 5 E-ISBN: 978 1 84569 312 1 £457.50/US$755.00/€550.00 www.woodheadpublishing.com/9781855735705

Woodhead Publishing Series in Textiles No. 113

Textiles play a vital role in the manufacture of various medical implants including the replacement of diseased or non-functioning parts of the body. Biotextiles as medical implants provides an invaluable single source of information on the main types of textile materials and products used for medical implants. Chapters in the first part of the book are concerned with the manufacture, properties and types of biotextiles used for medical applications, while the second part of the book provides a concise overview of the various medical applications of biotextiles, including stents, drug delivery systems and medical sutures. The book is an invaluable reference for manufacturers, designers, producers of textile implant materials. It will also be of interest to professionals within the healthcare industry, including scientists, nurses and students. CONTENTS

Part 1 Technologies: Manufacture, types and properties of biotextiles for medical applications; Nanofiber structures for medical biotextiles; Resorbable polymers for medical applications; Shaped biotextiles for medical implants; Surface modification of biotextiles for medical applications; Sterilization techniques for biotextiles for medical applications; Regulation of biotextiles for medical use; Retrieval studies for medical biotextiles. Part 2 Applications: Drug delivery systems (DDS) using biotextiles; Types and properties of surgical sutures; Materials for absorbable and non-absorbable surgical sutures; Surgical knot performance in sutures; Barbed suture technology; Small diameter arterial grafts using biotextiles; Vascular prostheses for open surgery; Biotextiles as percutaneous heart valves; Biotextiles as vena cava filters; Biotextiles for atrial septal defect repair; Hemostatic wound dressings; Anterior cruciate ligament prostheses using biotextiles; Endovascular prostheses for aortic aneurysms: a new era for vascular surgery.

Published in association with The Textile Institute 704 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 84569 439 5 E-ISBN: 978 0 85709 560 2 £200.00/US$330.00/€240.00 www.woodheadpublishing.com/9781845694395

Smart textiles for medicine and healthcare Materials, systems and applications Edited by L Van Langenhove, University of Ghent, Belgium Woodhead Publishing Series in Textiles No. 63 Published in association with The Textile Institute 336 pages 234 x 156mm (6 x 9) hardback 2007 ISBN: 978 1 84569 027 4 E-ISBN: 978 1 84569 293 3 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9781845690274

Find us on Twitter: @WoodheadTweets, Facebook at: /WoodheadPublishingLimited and Linkedin: /company/woodhead-publishing-limited

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Technologies and performance NEW Science of compression bandages

Textiles for hygiene and infection control

B Kumar, A Das and R Alagirusamy, IIT Delhi, India

Edited by B J McCarthy, TechniTex Faraday Limited, UK

Compression treatment for chronic venous diseases is associated with a wide range of challenges and often produces uncertain clinical outcomes. Investigating and exploiting the performance of compression bandage would further improve the knowledge of compression management and would give a holistic picture of this promising area. This book discusses the fundamentals of compression therapy i.e. compression or pressure through multi-disciplinary approaches involving various concepts of physics, biological science, biomaterials, fabric engineering, structural dynamics, material science, technical textiles and instrumentation to better deal with compression bandaging from different perspectives.

Woodhead Publishing Series in Textiles No. 108 CONTENTS

CONTENTS

Introduction to compression therapy; Bandage; Sub-bandage pressure; Compression performance under static state; Effect of material and structure on compression; Compression performance under dynamic state; Assessment of dynamic stiffness index; Time dependent study of compression management under dynamic conditions; Modelling of subbandage pressure profile generated over time.

A Woodhead Publishing India title 250 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 78242 268 6 E-ISBN: 978 1 78242 272 3 Approx. £95.00/US$155.00/€115.00 www.woodheadpublishing.com/9781782422686

Handbook of medical textiles

Part 1 Design and production techniques for hygiene textiles: The design of novel hygiene textile products; Nanotechnology and its applications in medical hygiene textiles; Use of knitted spacer fabrics for hygiene applications; Innovative and sustainable packaging strategies for hygiene products; Biodegradable hygiene products. Part 2 Design and production techniques for infection-control textiles: Microorganisms, infection and the role of textiles; Creating barrier textiles through plasma processing; Disposable and reusable medical textiles; Ensuring fabrics survive sterilisation. Part 3 Product types: Washable textile-based absorbent products for incontinence; Biological containment suits used in microbiological high containment facilities and by emergency responders; Coated textiles for skin infections; Antimicrobial treatments of textiles for hygiene and infection control applications: An industrial perspective.

Published in association with The Textile Institute 240 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 636 8 E-ISBN: 978 0 85709 370 7 £132.50/US$220.00/€160.00 www.woodheadpublishing.com/9781845696368

Medical and healthcare textiles Edited by S C Anand, University of Bolton, J F Kennedy, Chembiotech Ltd, M Miraftab and S Rajendran, University of Bolton, UK Woodhead Publishing Series in Textiles No. 75 Published in association with The Textile Institute 560 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 224 7 E-ISBN: 978 0 85709 034 8 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9781845692247

Edited by V Bartels, Bartels Scientific Consulting GmbH, Germany

Medical textiles and biomaterials for healthcare

Woodhead Publishing Series in Textiles No. 100

Edited by S C Anand, University of Bolton, J F Kennedy, Chembiotech Ltd, UK, M Miraftab and S Rajendran, University of Bolton

CONTENTS

Part 1 Types and properties of medical textiles: Modern textiles and biomaterials for healthcare; Hi-tech textiles for interactive wound therapies; Reusable medical textiles; Nonwoven materials and technologies for medical applications; Textiles for implants and regenerative medicine; Textiles with cosmetic effects; Drug-releasing textiles; Medical textiles and thermal comfort. Part 2 Textiles and the skin: Contact sensations of medical textiles on the skin; Mechanical skin irritations due to textiles; Allergies caused by textiles; Biofunctional textiles based on cellulose and their approaches for therapy and prevention of atopic eczema. Part 3 Textiles for hygiene: Infection prevention and control and the role of medical textiles; Absorbent products for personal health care and hygiene; Bio-functional textiles; Hospital laundries and their role in medical textiles; Odour control of medical textiles. Part 4 Medical textile case studies and applications: Textiles for medical filters; Textiles for patient heat preservation during operations; Evaluation of occupational clothing for surgeons: Achieving comfort and avoiding physiological stress through suitable gowns; Superabsorbents and their medical applications; Nanofibrous textiles in medical applications.

Woodhead Publishing Series in Textiles No. 48

Published in association with The Textile Institute

360 pages 234 x 156mm (6 x 9) hardback 2009 ISBN: 978 1 84569 271 1 E-ISBN: 978 1 84569 630 6 £147.50/US$245.00/€175.00 www.woodheadpublishing.com/9781845692711

608 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 691 7 E-ISBN: 978 0 85709 369 1 £182.50/US$300.00/€220.00 www.woodheadpublishing.com/9781845696917

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520 pages 234 x 156mm (6 x 9) hardback 2005 ISBN: 978 1 85573 683 2 E-ISBN: 978 1 84569 410 4 £182.50/US$300.00/€220.00 www.woodheadpublishing.com/9781855736832

Advanced textiles for wound care Edited by S Rajendran, University of Bolton, UK

TECHNOLOGIES AND PERFORMANCE NEW Biophotonics for medical applications Edited by I Meglinski, University of Otago, New Zealand Woodhead Publishing Series in Biomaterials No. 82

The field of biophotonics is concerned with the interface between laser optics and cell biology/medicine. In particular, biophotonic technologies allow scientists to create new tools for analysing and manipulating nano and macro scale objects. This book discusses the development and application of photonic techniques which aid the diagnosis and therapeutics of biological tissues in both healthy and diseased states. Chapters discuss the fundamental technologies used in biophotinics and a wide range of therapeutic and diagnostic applications. CONTENTS

Multimodal biomedical imaging; Optical fibres and sensors; Biomedicine with SERS; Optical biopsy in prostate cancer detection; Biophonitcs for cancer treatment; Therapeutic photonics in pulmonary medicine; Laser processing of medical devices; Tissue oxygenation analysis; Biophotonics in dental health; Assessing skin flap survival.

330 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 0 85709 662 3 E-ISBN: 978 0 85709 674 6 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9780857096623

Degradation rate of bioresorbable materials Prediction and evaluation Edited by F J Buchanan, Queen’s University Belfast, UK Woodhead Publishing Series in Biomaterials No. 13 CONTENTS

Part 1 Introduction. Part 2 Degradation mechanisms: Synthetic bioresorbable polymers. Part 3 Bioresorption test methods. Part 4 Factors influencing bioresorption. Part 5 Clinical application.

424 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 329 9 E-ISBN: 978 1 84569 503 3 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9781845693299

Woodhead Publishing Series in Textiles No. 85 ‘…a detailed and thorough look into this exciting application of textiles.’

International Textile and Apparel Association Published in association with The Textile Institute

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Available / will be available on Woodhead Publishing Online


Technologies and performance NEW Computational modelling of biomechanics and biotribology in the musculoskeletal system

NEW Modelling degradation of bioresorbable polymeric medical devices

Biomaterials and tissues regeneration

Edited by J Pan, University of Leicester, UK

Edited by Z Jin, University of Leeds, UK

Woodhead Publishing Series in Biomaterials No. 83

Woodhead Publishing Series in Biomaterials No. 81

Modelling is an important aspect of the design process for biomaterials and medical devices. By effectively modelling biomaterials and implants before their implantation, it is now possible to predict certain implanttissue reactions, degradation and wear. Consequently, computational modelling is becoming increasingly important in the design and manufacture of biomedical materials, allowing scientists to more accurately tailor their materials’ properties for the in vivo environment. Computational modelling of biomechanics and biotribology in the musculoskeletal system begins with an introduction to the field and the software and technologies. Part two covers generic modelling of cells and tissues whilst chapters in part three discuss modelling of biomaterials and interfaces. Part four reviews biomechanics and biotribology with chapters in part five discussing applications of modelling for joint replacements and tissue engineering. CONTENTS

Part 1 Introduction: Fundamentals of computational modelling; Software. Part 2 Generic modelling of cells and tissues: Computational modelling of cell mechanics; Computational modelling of soft tissues and ligaments; Computational modelling of cartilage; Computational modelling of bone and bone remodelling; Modelling fracture processes in bones. Part 3 Generic modelling of biomaterials and interfaces: Computational modelling of polymeric biomaterials; Modelling fatigue of bone cement; Modelling fracture processes in orthopaedic implants; Modelling orthopaedic fixation. Part 4 Generic modelling of biomechanics and biotribology: Finite element modelling in the musculoskeletal system; Computational modelling of Muscle biomechanics; Joint wear simulation. Part 5 Applications of computational modelling for joint replacements and tissue regeneration: Computational modelling of hip implants; Computational modelling of knee implants; Computational modelling of spinal implants; Computer aided design of bone tissue scaffolds.

570 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 0 85709 661 6 E-ISBN: 978 0 85709 673 9 Approx. £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9780857096616

The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices. The final set of chapters looks at advances in modelling biodegradation of bioresorbable polymers. This book is an essential guide to those concerned with replacing tests and experiments with modelling. CONTENTS

Part 1 Fundamentals of biodegradation of bioresorbable polymer devices: Introduction to bioresorbable medical devices and the need for computer modelling; Degradation pathway of bioresorbable polymer devices. Part 2 Degradation theories for bioresorbable polymers and devices: Modelling biodegradation of amorphous bioresorbable polymers; Modelling biodegradation of semicrystalline bioresorbable polymer devices; Modelling biodegradation of polymer/TCP composites devices; Degradation of mechanical properties of bioresorbable polymers. Part 3 Advanced topics in modelling biodegradation of bioresorbable polymers: Effective diffusion coefficient in degrading polymer devices; Finite element analysis of polymer device biodegradation.

NEW Biomedical imaging Applications and advances Edited by P Morris, University of Nottingham, UK Woodhead Publishing Series in Biomaterials No. 63

The development of imaging techniques is of great importance for the monitoring of medical implants, diagnosis of disease and for strategies for personalised medicine. Significant advances are being made in this technology and this book discusses the latest advances and developments in this increasingly important field. The book begins with an introduction to the field and its various technologies. Following on from this, chapters provide readers with a wide ranging review of medical applications such as brain, ophthalmic, musculoskeletal and whole body imaging. This text will be invaluable to those concerned with imaging and diagnosis. CONTENTS

Part 1 Imaging technologies: Biomedical Positron Emission Tomograpgy (PET) imaging; Atomic Force Microscopy (AFM) in biomedical research; Next Generation techniques for biomedical imaging. Part 2 Application specific biomedical imaging techniques: Brain imaging: Assessing therapy responses; Neural brain activation imaging; Ophthalmic imaging of ocular circulation for detecting disease; Intravascular Magnetic resonance imaging (MRI); Cardiovascular magnetic resonance imaging (MRI); Imaging methods for detection of joint degeneration; Whole body magnetic resonance imaging (MRI).

330 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 127 7 E-ISBN: 978 0 85709 747 7 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9780857091277

300 pages 234 x 156mm (6 x 9) hardback Q3 2014 ISBN: 978 1 78242 016 3 E-ISBN: 978 1 78242 025 5 Approx. £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781782420163

Woodhead Publishing Online Woodhead Publishing Online is the only place the full collection of Woodhead e-books is available. Comprising over 1000 e-books and 17,000 chapters, the content provides an authoritative summary of key research, allowing readers to keep upto-date with major trends. The site offers extensive features and functionality including no DRM, no limit to the number of concurrent users and a range of innovative purchase options.

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35


Technologies and performance NEW Rapid prototyping of biomaterials Principles and applications

NEW Microfluidic devices for biomedical applications

Edited by R Narayan, University of North Carolina, USA

Edited by X-J Li, University of Texas and Y Zhou, Genus Plc, USA

Woodhead Publishing Series in Biomaterials No. 70

Woodhead Publishing Series in Biomaterials No. 61

Rapid prototyping techniques, like the Inkjet Printer, are capable of building complex structures. These techniques have been used frequently in mechanical engineering and this technology has now been proven to successfully build biomaterials. The technology is particularly useful as the layer by layer fabrication approach also allows the internal architecture to be controlled. Chapters in this book firstly cover the fundamentals of additive manufacturing and its various related technologies. Further chapters continue to discuss a wide range of medical applications from tissue engineering and biosensors to printed prosthetic limbs.

Microfluidic devices are used to manipulate fluid such as blood, cell suspensions and therapies. This important technology is suitable for numerous applications from drug delivery to tissue engineering. The use of microfluidics in medicine is still evolving and microfluidic devices can be cheaply made and are small, applications are continually being researched and produced in the medical field. This important book discusses the fundamentals of microfluidics and will provide information on a wide range of medical applications. The first set of chapters discuss the fundamentals of microfluidic devices for medical applications. Subsequent chapters look at drug delivery applications, applications in cell biology, tissue engineering and diagnostics. In the final set of chapters, sensing applications are then reviewed.

CONTENTS

Introduction to rapid prototyping of biomaterials; Freeform fabrication of nano-biomaterials using 3D printing; Rapid prototyping techniques for the fabrication of biosensors; Rapid prototyping technologies for tissue regeneration; Rapid prototyping of complex tissues with laser assisted bioprinting (LAB); Scaffolding hydrogels for rapid prototyping based tissue engineering; Bioprinting for constructing microvascular systems for organs; Feasibility of 3D scaffolds for organs; 3-D Organ printing technologies for tissue engineering applications; Rapid prototyping technology for bone regeneration; Additive manufacturing of a prosthetic limb.

328 pages 234 x 156mm (6 x 9) hardback Q1 2014 ISBN: 978 0 85709 599 2 E-ISBN: 978 0 85709 721 7 Approx. £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9780857095992

Medical modelling The application of advanced design and development techniques in medicine R Bibb, University of Wales, UK Woodhead Publishing Series in Biomaterials No. 5 CONTENTS

CONTENTS

Part 1 Fundamentals of microfluidic technologies for biomedical applications: Materials and methods for the microfabrication of microfluidic biomedical devices; Surface coatings for microfluidic-based biomedical devices; Actuation mechanisms for microfluidic biomedical devices; Digital microfluidics technologies for biomedical devices. Part 2 Applications of microfluidic devices for drug delivery and discovery: Controlled drug delivery using microfluidic devices; Microneedles for drug delivery applications; Microfluidic devices for drug discovery and analysis. Part 3 Applications of microfluidic devices for cellular analysis and tissue engineering: Microfluidic devices for cell manipulation; Microfluidic devices for automated micro-robotic cell injection and trapping; Microfluidic devices for developing tissue scaffolds; Microfluidic devices for stem cell analysis. Part 4 Applications of microfluidic devices in diagnostic sensing: Development of immunoassays for protein analysis on nanobioarray chips; Integrated microfluidic systems for genetic analysis; Low-cost assays in paper-based microfluidic biomedical devices; Microfluidic devices for viral detection; Microfluidics for monitoring and imaging pancreatic islets and β-cells; Microfluidic devices for radio chemical synthesis.

752 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 697 5 E-ISBN: 978 0 85709 704 0 £200.00/US$330.00/€240.00 www.woodheadpublishing.com/9780857096975

Basic human anatomy; Computed tomography scanning; Magnetic resonance scanning; Non contact surface scanning; Export data format and media; Using medical scan data; Physical reproduction; Case studies; Future developments, Bibliography.

312 pages 234 x 156mm (6 x 9) hardback 2006 ISBN: 978 1 84569 138 7 E-ISBN: 978 1 84569 200 1 £147.50/US$245.00/€175.00 www.woodheadpublishing.com/9781845691387

NEW Bio-tribocorrosion in biomaterials and medical implants Edited by Y Yan, University of Science and Technology Beijing, China Woodhead Publishing Series in Biomaterials No. 60

During their service life, most biomaterials and medical implants are vulnerable to tribological damage. In addition, the environments in which they are placed are often corrosive. The combination of triobology, corrosion and the biological environment has been named ‘biotribocorrosion’. Understanding this complex phenomenon is critical to improving the design and service life of medical implants. This important book reviews key recent research in this area. After an introduction to the topography of bio-tribocorrosion, part one discusses different types of tribocorrosion as well as the prediction of wear in medical devices. Part two looks at biological effects on tribocorrosion processes. Part three reviews the issue of bio-tribocrrosion in clinical practice, including dental and orthopaedic applications. CONTENTS

Topography in bio-tribocorrosion. Part 1 Wear-corrosion mechanisms in biomaterials: Synergistic mechanisms of bio-tribocorrosion in medical implants; Fretting corrosion processes and wear mechanisms in medical implants; Wear and corrosion in the loosening of total joint replacements (TJRs); Abrasion-corrosion mechanisms of implant materials; Wear prediction in dental composites. Part 2 Bio-tribocorrosion and the biological environment: Growth of passive tribo-films in medical implants; Biofilms in the oral environment; Influence of protein adsorption on corrosion of biomedical alloys. Part 3 Bio-tribocorrosion in the clinical environment: Bio-tribocorrosion in dental applications; Corrosion resistant coatings for dental implants; Biotribocorrosion: surface interactions in total joint replacement (TJR); Tribocorrosion in artificial joints: in vitro testing and clinical implications; Testing protocol for the study of bio-tribocorrosion.

432 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 540 4 E-ISBN: 978 0 85709 860 3 £150.00/US$250.00/€180.00 www.woodheadpublishing.com/9780857095404

Molecular interfacial phenomena of polymers and biopolymers Edited by P Chen, University of Waterloo, Canada Woodhead Publishing Series in Biomaterials No. 3 ‘…it will be valued by researchers and postgraduate students with interest in polymers or biopolymers.’ ‘All the sections are unique and specialised to the authors’ field of expertise.’

Materials World 712 pages 234 x 156mm (6 x 9) hardback 2005 ISBN: 978 1 85573 928 4 E-ISBN: 978 1 84569 083 0 £215.00/US$355.00/€260.00 www.woodheadpublishing.com/9781855739284

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Technologies and performance NEW Joining and assembly of medical materials and devices

NEW Lasers for medical applications

Edited by Y N Zhou, University of Waterloo, Canada and M D Breyen, Medtronic Inc, USA

Edited by H Jelinkova, Czech Technical University, Czech Republic

Woodhead Publishing Series in Biomaterials No. 54

Woodhead Publishing Series in Electronic and Optical Materials No. 37

As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications. Part one provides an introduction to medical devices and joining methods. Part two moves on to explore the joining and assembly of medical metals. Part three focuses on medical plastics. Finally, part four discusses the joining and assembly of biomaterial and tissue implants.

Lasers have a wide and growing range of applications in medicine. Lasers for medical applications summarises the wealth of recent research on the principles, technologies and application of lasers in diagnostics, therapy and surgery. Part one gives an overview of the use of lasers in medicine, key principles of lasers and radiation interactions with tissue. The respective types of the laser (solid state, gas, dye, and semiconductor) are reviewed in part two. Part three describes diagnostic laser methods, for example optical coherence tomography, spectroscopy, optical biopsy, and time-resolved fluorescence polarization spectroscopy. Part four concentrates on the therapeutic applications of laser radiation in particular branches of medicine.

CONTENTS

CONTENTS

Part 1 Fundamentals of joining and assembly in medical materials and devices: Introduction to medical materials and devices; Introduction to joining methods in medical applications; Micro-welding methods in medical components and devices; The effects of sterilization on medical materials and welded devices. Part 2 Joining and assembly of medical metals: Microwelding of shape memory alloys; Joining of platinum (Pt) alloys and stainless steel wires for electronic medical devices; Evaluating the corrosion performance of metal medical device welds; Laser hermetic welding of implantable medical devices; Validating hermeticity in welded metallic implantable medical devices. Part 3 Joining and assembly of medical plastics: Overview of welding methods for medical plastics; Ultrasonic welding of medical plastics; Radio frequency (RF)/dielectric welding of medical plastics; Transmission laser welding strategies for medical plastics; Bonding strategies and adhesives for joining medical device components. Part 4 Joining and assembly of biomaterial and tissue implants: Advanced metal-ceramic joining techniques for orthopaedic applications; Tissue adhesives and sealants for surgical applications; Antibacterial adhesives for bone and tooth repair; Testing bond strength: The case of dental biomaterials.

580 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 84569 577 4 E-ISBN: 978 0 85709 642 5 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9781845695774

Surfaces and interfaces for biomaterials Edited by P Vadgama, Queen Mary University of London, UK Woodhead Publishing Series in Biomaterials No. 2

824 pages 234 x 156mm (6 x 9) hardback 2005 ISBN: 978 1 85573 930 7 E-ISBN: 978 1 84569 080 9 £215.00/US$355.00/€260.00 www.woodheadpublishing.com/9781855739307

Diagnostics, therapy and surgery

Introduction: The history of lasers in medicine. Part 1 Lasertissue interaction: Laser characteristics; The response of tissue to laser light; Optical fibers for medical applications. Part 2 Types of laser used in medicine: Solid-state lasers for medical applications; Gas lasers for medical applications; Liquid and solid-state tunable organic dye lasers for medical applications; Semiconductor lasers for medical applications. Part 3 Lasers in diagnostics: Optical sources for optical coherence tomography (OCT); Laser spectroscopy in medical diagnostics; Optical biopsy for cancer detection; Time-resolved fluorescence polarization spectroscopy and optical imaging of smart receptor-targeted contrast agents in tissues for cancer detection. Part 4 Laser therapy and surgery: Laser therapy in ophthalmology; Lasers in dermatology; Lasers in cardiology; Lasers in urology; Lasers in gynecology; Lasers in otorhinolaryngology (ORL) and head and neck surgery; Lasers in neurology; Lasers in dentistry; Laser in orthopaedic surgery; Cancer laser therapy using gold nanoparticles; Hybrid laser technology for biomaterials; Laser safety: Regulations, standards, and guidelines for practice; Photodynamic therapy for human malignancies with superficial and interstitial illumination.

800 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 0 85709 237 3 E-ISBN: 978 0 85709 754 5 Approx. £210.00/US$345.00/€250.00 www.woodheadpublishing.com/9780857092373

Cellular response to biomaterials Edited by L Di Silvio, King’s College London, UK Woodhead Publishing Series in Biomaterials No. 16

648 pages 234 x 156mm (6 x 9) hardback 2008 ISBN: 978 1 84569 358 9 E-ISBN: 978 1 84569 547 7 £190.00/US$315.00/€230.00 www.woodheadpublishing.com/9781845693589

Non-metallic biomaterials for tooth repair and replacement Edited by P Vallittu, University of Turku, Finland Woodhead Publishing Series in Biomaterials No. 53

As the demand for healthy, beautiful teeth increases, the methods and materials employed in restorative dentistry have become progressively advanced. Non-metallic biomaterials for tooth repair and replacement focuses on the use of biomaterials for a range of applications in tooth repair and, in particular, dental restoration. CONTENTS

Part 1 Structure, modification and repair of dental tissues: Structure and properties of enamel and dentin; Biomineralization and biomimicry of tooth enamel; Enamel and dentin bonding for adhesive dental restorations; Enamel matrix proteins (EMP) for periodontal regeneration. Part 2 Dental ceramics and glasses for tooth repair and replacement: Processing and bonding of dental ceramics; Wear properties of dental ceramics; Sol-gel derived bioactive glass ceramics for dental applications. Part 3 Dental composites for tooth repair and replacement: Composite adhesive restorative materials for dental applications; Antibacterial composite restorative materials for dental applications; Effects of particulate filler systems on the properties and performance of dental polymer composites; Composite based oral implants; Fibre reinforced composites (FRCs) as dental materials; Luting cements for dental applications.

432 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 0 85709 244 1 E-ISBN: 978 0 85709 643 2 £145.00/US$240.00/€175.00 www.woodheadpublishing.com/9780857092441

Medical robotics Minimally invasive surgery Edited by P Gomes, Cambridge Consultants, UK Woodhead Publishing Series in Biomaterials No. 51

Advances in research have led to the use of robotics in a range of surgical applications. Medical robotics: Minimally invasive surgery provides authoritative coverage of the core principles, applications and future potential of this enabling technology. CONTENTS

Introduction to robot-assisted Minimally Invasive Surgery (MIS); Localisation and tracking technologies for medical robotics; Robotics for neurosurgery; Robotic systems for cardiovascular interventions; Robotics in orthopaedic surgery; Robotic-assisted knee replacement surgery; Robotics in Ear, Nose and Throat (ENT) surgery; Robotic-assisted vitreoretinal surgery; Robotics for minimally invasive surgery (MIS) and natural orifice transluminal endoscopic surgery (NOTES); Meso-Scale mobile robots for gastrointestinal Minimally Invasive Surgery (MIS); Real-time software platform using magnetic resonance imaging (MRI) for in vivo navigation of magnetic microrobots; Robotic surgery and ethical issues.

320 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 0 85709 130 7 E-ISBN: 978 0 85709 739 2 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9780857091307

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37


Technologies and performance Biocompatibility and performance of medical devices

Sterilisation of biomaterials and medical devices

Durability and reliability of medical polymers

Edited by J-P Boutrand, Biomatech, France

Edited by S Lerouge, Ecole de Technologie Supérieure, Canada and A Simmons, University of New South Wales, Australia

Edited by M Jenkins and A Stamboulis, University of Birmingham, UK

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe, biocompatible, and perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces key concepts and challenges faced in relation to biocompatibility in medical devices. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing for soft and hard tissues implants discussed. Part four provides information on the international regulation of medical devices in the European Union, Japan and China, before concluding in part five with a review of histopathology principles for biocompatibility and performance studies.

Woodhead Publishing Series in Biomaterials No. 46

Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers.

CONTENTS

Introduction to sterilisation: Definitions and challenges; Steam and dry heat sterilisation of biomaterials and medical devices; Sterilisation of healthcare products by ionising radiation: Principles and standards; Ethylene Oxide (ETO) sterilisation of healthcare products; Non-traditional sterilisation techniques for biomaterials and medical devices; Sterilisation and decontamination of surfaces by plasma discharges; Sterilisation techniques for polymers; Sterilisation of healthcare products by ionising radiation: Sterilisation of drug-device products and tissue allografts; Antimicrobial coatings for self-sterilisation; Prions and endotoxins: Reprocessing strategies for reusable medical devices; Future trends for the sterilisation of biomaterials and medical devices.

Woodhead Publishing Series in Biomaterials No. 50

Part 1 Introduction to biocompatibility in medical devices: Concepts in biocompatibility: New biomaterials, new paradigms and new testing regimes; Challenges in biocompatibility and failure of biomaterials; Biological safety evaluation planning of biomaterials; Biomechanical and biochemical compatibility in innovative biomaterials. Part 2 Evaluation and characterisation of biocompatibility in medical devices: Material and chemical characterization for the biological evaluation of medical device biocompatibility; Allowable limits for toxic leachables: Practical Use of ISO–Standard; In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices; Practical approach to blood compatibility assessments: General considerations and standards; Medical device biocompatibility evaluation: An industry perspective; Case study: Overcoming negative tests results during manufacture; Methods for the characterisation and evaluation of drug-device combination products. Part 3 Testing and interpreting the performance of medical devices: Methods and interpretation of performance studies for bone implants; Methods and interpretation of performance studies for dental implants; Non-clinical functional evaluation of medical devices: General recommendations and examples for soft tissue implants; Mechanical testing for soft and hard tissues implants. Part 4 International regulation of medical devices: Biological evaluation and regulation of medical devices in the European Union; Biological evaluation and regulation of medical devices in Japan; Medical device regulations in China. Part 5 Histopathology principles for biocompatibility and performance studies: Microscopic and ultrastructural pathology in medical devices.

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. This book reviews the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. CONTENTS

352 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 932 1 E-ISBN: 978 0 85709 626 5 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9781845699321

Sterilisation of polymer healthcare products W Rogers 326 pages 255 x 190mm (7 1/2 x 10) paperback 2005 ISBN: 978 1 85957 490 4 £95.00/US$155.00/€115.00 www.woodheadpublishing.com/9781859574904 Not available for distribution in the USA.

540 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 0 85709 070 6 E-ISBN: 978 0 85709 645 6 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9780857090706

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Woodhead Publishing Series in Biomaterials No. 44

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CONTENTS

Part 1 Types and properties of bioresorbable medical polymers: Types of bioresorbable polymers for medical applications; The effect of molecular structure on the properties of biomedical polymers; Processing of bioresorbable and other polymers for medical applications; Understanding transport phenomena and degradation of bioresorbable medical polymers; Synthetic bioresorbable polymers; Using synthetic bioresorbable polymers for orthopaedic tissue regeneration. Part 2 Aspects of durability and reliability of non-bioresorbable medical polymers: Wear processes in polymer implants; Ageing processes of biomedical polymers in the body; The failure of synthetic polymeric medical devices; Manufacturing defects in polymeric medical devices.

296 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 929 1 E-ISBN: 978 0 85709 651 7 £132.50/US$220.00/€160.00 www.woodheadpublishing.com/9781845699291

Biointegration of medical implant materials Science and design Edited by C P Sharma, Sree Chitra Tirunal Institute for Medical Sciences and Technology, India Woodhead Publishing Series in Biomaterials No. 26 CONTENTS

Biointegration: An introduction. Part 1 Soft tissue biointegration: Biocompatibility of engineered soft tissue created by stem cells; Replacement materials for facial reconstruction at the soft tissue-bone interface; Corneal tissue engineering; Tissue engineering for small-diameter vascular graft; Stem cells for organ regeneration. Part 2 Drug delivery: Materials facilitating protein drug delivery and vascularisation; Inorganic nanoparticles for targeted drug delivery; Alginate-based drug delivery devices; Functionalised nanoparticles for targeted drug delivery. Part 3 Design considerations: Biocompatibility of Materials and its relevance to drug delivery and tissue engineering; Mechanisms of failure of medical implants during long-term use; Rapid prototyping in biomedical Engineering: Structural intricacies of biological materials.

424 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 509 5 E-ISBN: 978 1 84569 980 2 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9781845695095

Available / will be available on Woodhead Publishing Online


Technologies and performance Implantable sensor systems for medical applications Edited by A Inmann, Andreas Inmann Consulting, USA and D Hodgins, European Technology for Business Limited, UK Woodhead Publishing Series in Biomaterials No. 52

Implantable sensor systems offer great potential for enhanced medical care and improved quality of life, consequently leading to vast investment in this exciting field. Implantable sensor systems for medical applications provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of these devices in a diverse range of medical applications. CONTENTS

Part 1 Fundamentals of implantable systems: Materials for implantable systems; Material-tissue interfaces in implantable systems; Packaging and coating materials for implantable systems; Microassembly and micropackaging of implantable systems; Electrode array design and fabrication for implantable systems; Biofuel cells as sustainable power sources for implantable systems. Part 2 Challenges of implantable systems: Biocompatibility of implantable systems; Sterilisation considerations for implantable sensor systems; Protection of data confidentiality and patient privacy in medical sensor networks; Developing active implantable medical devices in a regulated environment. Part 3 Applications of implantable systems: Microelectromechanical systems (MEMS) for in-vivo applications; Tripolar interfaces for neural recording; Sensors for motor neuroprostheses; Implantable wireless body area networks; Retina implants.

544 pages 234 x 156mm (6 x 9) hardback 2013 ISBN: 978 1 84569 987 1 E-ISBN: 978 0 85709 628 9 £165.00/US$270.00/€200.00 www.woodheadpublishing.com/9781845699871

Biosensors for medical applications Edited by S Higson, Cranfield University, UK Woodhead Publishing Series in Biomaterials No. 45

Biosensors for medical applications provides a comprehensive review of established, cutting edge and future trends in biomedical sensors and their applications. CONTENTS

Part 1 Principles and transduction approaches: Electrochemical biosensors for medical applications; Piezoelectric biosensors for medical applications; Nano-sized biosensors for medical applications; Impedence interrogated affinity biosensors for medical applications: Novel targets and mechanistic studies; Practical applications and protocols for enzyme biosensors. Part 2 Applications of medical biosensors: Biosensors for DNA and RNA detection and characterization; Biosensors for disease biomarker detection; Affibodies as an alternative to antibodies in biosensors for cancer markers; Biosensors for drug testing and discovery; Biosensors for non-invasive measurements; Wearable biosensors for medical applications.

360 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 935 2 E-ISBN: 978 0 85709 718 7 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9781845699352

MEMS for biomedical applications Edited by S Bhansali and A Vasudev, Florida International University, USA Woodhead Publishing Series in Biomaterials No. 43

The application of Micro Electro Mechanical Systems (MEMS) in the biomedical field is leading to a new generation of medical devices. MEMS for biomedical applications reviews the wealth of recent research on fabrication technologies and applications of this exciting technology. Part one introduces the fundamentals of MEMS for biomedical applications, exploring the microfabrication of polymers and reviewing sensor and actuator mechanisms. Part two goes on to consider MEMS for biomedical sensing and diagnostic applications. MEMS for tissue engineering and clinical applications are the focus of part three. Finally, part four reviews emerging biomedical applications of MEMS, from implantable neuroprobes and ocular implants to cellular microinjection. CONTENTS

Part 1 Fundamentals of MEMS for biomedical applications: Microfabrication of polymers for bioMEMS; Review of sensor and actuator mechanisms for bioMEMS. Part 2 MEMS for biomedical sensing and diagnostic applications: MEMS for in vivo sensing; MEMS and electrical impedance spectroscopy (EIS) for non-invasive measurement of cells; MEMS ultrasonic transducers for biomedical applications; Lab-on-chip (LOC) devices and microfluidics for biomedical applications. Part 3 MEMS for tissue engineering and clinical applications: Fabrication of cell culture microdevices for tissue engineering applications; MEMS manufacturing techniques for tissue scaffolding devices; BioMEMS for drug delivery applications; Applications of MEMS technologies for minimally invasive medical procedures; Smart Microgrippers for bioMEMS applications; Microfluidic techniques for the detection, manipulation and isolation of rare cells. Part 4 Emerging biomedical applications of MEMS: MEMS as implantable neuroprobes; MEMS as ocular implants; Cellular microinjection for therapeutics and research applications; Hybrid MEMS: Integrating inorganic structures into live organisms.

512 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 0 85709 129 1 E-ISBN: 978 0 85709 627 2 £160.00/US$265.00/€190.00 www.woodheadpublishing.com/9780857091291

Developments in tissue engineered and regenerative medicine products A practical approach J Basu and J W Ludlow, Tengion Inc, USA Woodhead Publishing Series in Biomaterials No. 48

Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized. Roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete ‘how-to’ manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing. CONTENTS

Overview of tissue engineering/regenerative medicine; Cells; Biomaterials for TE/RM products; Neo-Bladder: A foundational technology platform for tubular organ regeneration; Neo-Urinary Conduit™; Tissue engineering of non-bladder tubular organs; Tissue engineering of solid organs; Regulatory and quality control; Pre-clinical and clinical evaluation of TE/RM products; Manufacturing; Intellectual property.

226 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 907568 76 3 E-ISBN: 978 1 908818 11 9 £130.00/US$215.00/€155.00 www.woodheadpublishing.com/9781907568763

Electrospinning for tissue regeneration Edited by L Bosworth and S Downes, University of Manchester, UK Woodhead Publishing Series in Biomaterials No. 35 CONTENTS

Part 1 Fundamentals of electrospinning: Introduction to electrospinning; Polymer chemistry; The electrospinning process, conditions and control; Regulatory issues relating to electrospinning. Part 2 Electrospinning for tissue regeneration: Bone tissue regeneration; Cartilage tissue regeneration; Muscle tissue regeneration; Tendon tissue regeneration; Nerve tissue regeneration; Heart valve tissue regeneration; Bladder tissue regeneration; Tracheal tissue regeneration; Dental regeneration; Skin tissue regeneration; Wound dressings. Part 3 Electrospinning for in vitro applications applications: Cell culture systems for kidney research; Cell culture systems for pancreatic research; Cell culture systems for stem cell research.

424 pages 234 x 156mm (6 x 9) hardback 2011 ISBN: 978 1 84569 741 9 E-ISBN: 978 0 85709 291 5 £140.00/US$230.00/€170.00 www.woodheadpublishing.com/9781845697419

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Technologies and performance Minimized cardiopulmonary bypass techniques and technologies Edited by T Gourlay, University of Strathclyde, UK and S Gunaydin, K. Kale University, Turkey Woodhead Publishing Series in Biomaterials No. 40

Traditional cardiopulmonary bypass (CPB) techniques have suffered from a number of disadvantages including haemodilution, inflammation and post-operative bleeding. Minimised cardiopulmonary bypass techniques use developments in perfusion technology to significantly reduce foreign surface-blood interactions to make bypass simpler and safer. This important book reviews key developments and issues relating to this promising technology. CONTENTS

Part 1 Introduction to minimized cardiopulmonary bypass: Historical development of minimized cardiopulmonary bypass; Anticoagulation protocols for minimized cardiopulmonary bypass; Minimized extracorporeal circulation: Physiology and pathophysiology; Blood–surface interface in miniatururised extracorporeal circulation systems; Hemodilution: Physiology and pathophysiology; Inflammatory response and minimized cardiopulmonary bypass. Part 2 Minimized cardiopulmonary bypass equipment: Design and principles of the minimized extracorporeal circuit; Cardiopulmonary bypass perfusate; Myocardial preservation techniques for mini-bypass. Part 3 Clinical applications of minimized cardiopulmonary bypasses: Minimized cardiopulmonary bypass: Objectives and indications; Coronary artery bypass grafting (CABG); Valve surgery using minimized perfusion circuits; Minimising cardiopulmonary bypass in children; Comparison of minimized circulation with off-pump coronary artery bypass grafting (OPCAB) and conventional surgery; Minimally invasive cardiac surgery, port-access and robotic surgery.

272 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 800 3 E-ISBN: 978 0 85709 602 9 £132.50/US$220.00/€160.00 www.woodheadpublishing.com/9781845698003

Sterilisation of tissues using ionising radiations Edited by J F Kennedy, University of Birmingham, G O Phillips, Phillips Hydrocolloid Research Ltd and P A Williams, The North East Wales Institute, UK Woodhead Publishing Series in Biomaterials No. 1 352 pages 244 x 172mm (6 1/2 x 9 1/2) hardback 2005 ISBN: 978 1 85573 838 6 E-ISBN: 978 1 84569 077 9 £182.50/US$300.00/€220.00 www.woodheadpublishing.com/9781855738386

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Progenitor and stem cell technologies and therapies

Surface modification of biomaterials Methods analysis and applications

Edited by A Atala, Wake Forest Institute of Regenerative Medicine, USA

Edited by R Williams, University of Liverpool, UK

Woodhead Publishing Series in Biomaterials No. 38

Progenitor and stem cells have the ability to renew themselves and change into a variety of specialised types, making them ideal materials for therapy and regenerative medicine. Progenitor and stem cell technologies and therapies reviews the range of available progenitor and stem cells and their therapeutic application. CONTENTS

Part 1 Basic principles of stem cells: Basic principles for stem cell culture; Basic principles of human embryonic stem cells; Basic principles in generating induced pluirpotent stem cells; Basic principles of amniotic and placental stem cells; Basic principles of cord blood stem cells; Basic principles of multipotent stem cells. Part 2 Enabling cell therapy: Intellectual property claims to stem cell technologies: Research, clinical testing and product sales; Regulatory considerations of stem and progenitor cell-based products: US Food and Drug Administration; Cell therapy commercialisation; Stem cell tourism. Part 3 Tissue-specific progenitor cells: Adipose tissue-derived stem cell biology and therapy; Umbilical cord blood (UCB) progenitor stem cell biology and therapy; Auditory progenitor stem cell biology and therapy; Olfactory mucosa: Neural stem and progenitor cells for nervous system repair and cell models of brain disease; Oral cavity progenitor and stem cell biology and therapy; Bone marrow mesenchymal progenitor and stem cell biology and therapy; Progenitor and stem cell therapies for cartilage repair; Cardiac stem and progenitor cell biology and therapy; Renal progenitor and stem cell biology and therapy; Lung progenitor and stem cell biology and therapy; Genitourinary progenitor and stem cell biology and therapy.

568 pages 234 x 156mm (6 x 9) hardback 2012 ISBN: 978 1 84569 984 0 E-ISBN: 978 0 85709 607 4 £170.00/US$280.00/€205.00 www.woodheadpublishing.com/9781845699840

Woodhead Publishing Series in Biomaterials No. 28 CONTENTS

Part 1 Surface modification techniques: Surface modification of biomaterials by plasma polymerisation; Surface modification of biomaterials by covalent binding of poly(ethylene glycol) (PEG); Surface modification of biomaterials by heparinisation to improve blood compatibility; Surface modification of biomaterials by peptide functionalisation; Metal surface oxidation and surface interactions; Surface modification of biomaterials by calcium phosphate deposition; Biomaterial surface topography to control cellular response: Technologies, cell behaviour and biomedical applications. Part 2 Analytical techniques and applications: Techniques for analysing biomaterial surface chemistry; Techniques for analysing biomaterial surface structure, morphology and topography; Modifying biomaterial surfaces to optimise interactions with blood; Modifying biomaterials surfaces with bioactives to control infection; Modifying biomaterial surfaces to optimise interactions with soft tissues; Modifying biomaterial surfaces for the repair and regeneration of nerve cells; Modifying biomaterial surfaces to control stem cell growth and differentiation; Modifying biomaterial surfaces to optimise interactions with bone.

436 pages 234 x 156mm (6 x 9) hardback 2010 ISBN: 978 1 84569 640 5 E-ISBN: 978 0 85709 076 8 £147.50/US$245.00/€175.00 www.woodheadpublishing.com/9781845696405

Tissue engineering using ceramics and polymers Edited by A R Boccaccini, Imperial College London and J Gough, University of Manchester, UK Woodhead Publishing Series in Biomaterials No. 8

Biomaterials, artificial organs and tissue engineering

624 pages 234 x 156mm (6 x 9) hardback 2007 ISBN: 978 1 84569 176 9 E-ISBN: 978 1 84569 381 7 £190.00/US$315.00/€230.00 www.woodheadpublishing.com/9781845691769

Edited by L Hench and J Jones, Imperial College of Science, Technology and Medicine, UK Woodhead Publishing Series in Biomaterials No. 4

Artificial cells, cell engineering and therapy

‘…highly useful for students of biomaterials, material science and medicine.’

Edited by S Prakash, McGill University, Canada

International Journal of Biological Macromolecules 304 pages 234 x 156mm (6 x 9) paperback + CD-ROM 2005 ISBN: 978 1 85573 737 2 E-ISBN: 978 1 84569 086 1 £52.50/US$85.00/€65.00 www.woodheadpublishing.com/9781855737372

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Woodhead Publishing Series in Biomaterials No. 6

544 pages 234 x 156mm (6 x 9) hardback 2007 ISBN: 978 1 84569 036 6 E-ISBN: 978 1 84569 307 7 £175.00/US$290.00/€210.00 www.woodheadpublishing.com/9781845690366

Available / will be available on Woodhead Publishing Online


Title index 21st Century quality management and good management practices, 12, 14 Advanced textiles for wound care, 34 Advanced wound repair therapies, 26 Advancement in carrier-based drug delivery, 17 Allergens and respiratory pollutants, 16 An introduction to biotechnology, 2, 8 An introduction to pharmaceutical sciences, 18 Annotating new genes, 4, 6 Application of statistical process control in the pharmaceutical and biotechnology industries, The, 11, 13 Artificial cells, cell engineering and therapy, 40 Bacterial cellular metabolic systems, 9 Bioactive glasses, 33 Bioactive materials in medicine, 30 Biobanks, 7 Bioceramics and their clinical applications, 32 Biocompatibility and performance of medical devices, 38 Bioinformatics for biomedical science and clinical applications, 3, 15 Biointegration of medical implant materials, 38 Biomaterials and devices for the circulatory system, 23 Biomaterials and medical tribology, 31 Biomaterials and regenerative medicine in ophthalmology, 27 Biomaterials and tissue engineering in urology, 28 Biomaterials for artificial organs, 26 Biomaterials for cancer therapeutics, 24 Biomaterials for spinal surgery, 26 Biomaterials for treating skin loss, 28 Biomaterials in plastic surgery, 26 Biomaterials, artificial organs and tissue engineering, 40 Biomedical composites, 31 Biomedical foams for tissue engineering applications, 23 Biomedical hydrogels, 33 Biomedical imaging, 35 Biomedical polymers, 31 Biomimetic biomaterials, 31 Biophotonics for medical applications, 34 Biosensors for medical applications, 39 Biotech manager’s handbook, A, 3, 12 Biotextiles as medical implants, 33 Bio-tribocorrosion in biomaterials and medical implants, 36 Bone repair biomaterials, 27 Bone substitute biomaterials, 29 CAPA in the pharmaceutical and biotech industries, 11, 13 Cardiac regeneration and repair, 23 Cellular response to biomaterials, 37 Characterization of biomaterials, 32 Clinical research in Asia, 13, 21 Clinical research in paediatric psychopharmacology, 17 Clinical trial management, 17

Coatings for biomedical applications, 33 Commercializing the stem cell sciences, 12, 22 Computational modelling of biomechanics and biotribology in the musculoskeletal system, 35 Computer-aided applications in pharmaceutical technology, 3, 20 Computer-aided vaccine design, 4 Concepts and techniques in genomics and proteomics, 6, 9 Contract research and manufacturing services (CRAMS) in India, 7, 12 Controlled drug delivery, 17 Decontamination in hospitals and healthcare, 29 Degradation rate of bioresorbable materials, 34 Dental biomaterials, 27 Deterministic versus stochastic modelling in biochemistry and systems biology, 3 Developments in tissue engineered and regenerative medicine products, 22, 39 Diamond-based materials for biomedical applications, 32 Drug-biomembrane interaction studies, 19 Drug-device combination products, 27 Durability and reliability of medical polymers, 38 Electroporation-based therapies for cancer, 2, 15 Electrospinning for tissue regeneration, 39 Fed-batch fermentation, 7 Formulation tools for pharmaceutical development, 20 From plant genomics to plant biotechnology, 2, 8 Funding of biopharmaceutical research and development, The, 11 Gene expression analysis in the RNA world, 5, 8 Gene therapy, 5 Handbook of cosmeceutical excipients, 18 Handbook of medical textiles, 34 Hip resurfacing handbook, The, 28 Human papillomavirus infections, 9, 16 Hyaluronan, 33 Impact of regulation on drug development, The, 6, 10 Implantable sensor systems for medical applications, 39 Imported infectious diseases, 15 Inhaler devices, 25 Injectable biomaterials, 33 Innovative brain tumor therapy, 14 Joining and assembly of medical materials and devices, 37 Joint replacement technology, 22 Lasers for medical applications, 37 Lean biomanufacturing, 11, 14

Life-cycle of pharmaceuticals in the environment, The, 17 Marine enzymes for biocatalysis, 8 Materials science for dentistry, 27 MATLABÂŽ in bioscience and biotechnology, 2, 5 Medical and healthcare textiles, 34 Medical education, training and care delivery in a virtual world, 15 Medical modelling, 36 Medical robotics, 37 Medical textiles and biomaterials for healthcare, 34 MEMS for biomedical applications, 39 Metals for biomedical devices, 30 Microfluidic devices for biomedical applications, 36 Minimized cardiopulmonary bypass techniques and technologies, 40 Modelling degradation of bioresorbable polymeric medical devices, 35 Molecular interfacial phenomena of polymers and biopolymers, 36 Nanomaterials in tissue engineering, 24 Nanomedicine, 25 Nanoparticle-based approaches to targeting drugs for severe diseases, 16, 19 Nanoparticulate drug delivery, 16 Natural-based polymers for biomedical applications, 31 New functional biomaterials for medicine and healthcare, 31 NMR metabolomics in cancer research, 16 Non-metallic biomaterials for tooth repair and replacement, 37 Novel biomaterials for bone regeneration, 24 Ocular transporters and receptors, 19 Open source software in life science research, 4, 10 Oral delivery of insulin, 18 Orphan drugs, 11, 18 Orthopaedic bone cements, 27 Outsourcing biopharma R&D to India, 12 Patently innovative, 7, 13 Perspectives in total hip arthroplasty, 28 Porous silicon for biomedical applications, 30 Practical approach to spinal trauma, A, 29 Practical leadership for biopharmaceutical executives, 12 Precious metals for biomedical applications, 30 Preprosthetic and maxillofacial surgery, 29 Progenitor and stem cell technologies and therapies, 40 Protein folding in silico, 4 Quality assurance, 6 Rapid prototyping of biomaterials, 36 Regenerative medicine and biomaterials for the repair of connective tissues, 27 Regulatory affairs for biomaterials and medical devices, 29 Science of compression bandages, 34

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41


Title index Semiconducting silicon nanowires for biomedical applications, 30 Shape memory alloys for biomedical applications, 32 Silk for biomaterials and tissue engineering applications, 23 Smart textiles for medicine and healthcare, 33 Standardisation in cell and tissue engineering, 25 Stem cell bioprocessing, 14, 22 Sterilisation of biomaterials and medical devices, 38 Sterilisation of polymer healthcare products, 38 Sterilisation of tissues using ionising radiations, 40 Sterility, sterilisation and sterility assurance for pharmaceuticals, 20 Successful biopharmaceutical operations, 10 Surface modification of biomaterials, 40 Surfaces and interfaces for biomaterials, 37 Textiles for hygiene and infection control, 34 Therapeutic antibody engineering, 9, 21 Therapeutic protein drug products, 9, 21 Therapeutic risk management of medicines, 10, 18 Tissue engineering using ceramics and polymers, 40 Translational biology in medicine, 15 Transporters in drug discovery and development, 19 Ultrafiltration for bioprocessing, 8, 13 Wear of orthopaedic implants and artificial joints, 32

42

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Author index Affatato, S 28, 32 Aguilar, J E 20 Alagirusamy, R 34 Amato, S 29 Ambrosio, L 26, 31 Anand, S C 34 Antani, M 7, 12 Archer, C 27 Arias, J L 16, 19 Arinzeh, T 32 Assaad, E 17 Atala, A 28, 40 Auby, P 17 Azevedo, H S 31 Bajaj, H N 29 Baltzer, N 30 Banerjee, A K 10, 18 Bartels, V 34 Basu, J 22, 39 Bazaka, K 31 Best, S M 27 Bhansali, S 39 Bibb, R 36 Black, R 23 Blanco, C 28 Boccaccini, A R 40 Bosworth, L 39 Bouchard, R A 7, 13 Boutrand, J-P 38 Brandon, H 26 Braund, R 17 Breyen, M D 37 Buchanan, F J 34 Burbulis, N 2, 8 Burstein, L 2, 5 Cabral, J M S 14, 22 Caffo, M 14 Campbell, P 28 Caruso, G 14 Chen, P 36 Chin, J Y 12 Chirila, T V 27 Chowdhury, P R 12 Clement, J Q 5, 8 Cobo, F 9, 15, 16 Cochrane, T 11, 13 Coffer, J L 30 Copponnex, T 30 Courtney, J M 31 Crawford, R J 31 Cuperlovic-Culf, M 16 Curtis, R V 27 Dandekar, P 16 Darvell, B W 27 Das, A 34 De Robbio, A 7 De Smet, K 28 Deb, S 27 Denstedt, J 28 Di Silvio, L 37 Diogo, M M 14, 22 Djuris, J 3, 20 Downes, S 39 Driscoll, C 10 Driver, M 33

Dubruel, P 24 Ezzell, B 29 Farrar, D 26 Fernandes, T G 14, 22 Ferri, J 29 Fogher, C 2, 8 Forster, M 4, 10 Gaharwar, A K 24 Godbey, W T 2, 8 Gokhale, G 7, 12 Gomes, M E 31 Gomes, P 37 Gough, J 40 Gourlay, T 23, 40 Guidoin, R 33 Gunaydin, S 40 Gupta, B S 33 Hacking, S A 24 Hammond, W 32 Hancock, M J 24 Harland, L 4, 10 Harvey, O 12, 22 Hascall, V C 33 Hench, L 40 Hennings, G H 6, 10 Hernberg-Stahl, E 11, 18 Higson, S 39 Hodgins, D 39 Hopkins, M M 3, 12 Hunziker, E 29 Inmann, A 39 Ispas-Szabo, P 17 Ivanova, E P 31 Jaffe, M 32 Jain, A 17 Jain, R 16 Jain, S K 17 Jelinkova, H 37 Jenkins, M 31, 38 Jerina, K L 26 Jin, Z 35 Jones, J 40 Jordan, F 3

Li, X-J 36 Liang, K-H 3, 15 Ludlow, J W 22, 39 Lutz, H 8, 13 Lysaght, M 26 Mallick, K 29 Mano, J F 31 Marques, A P 31 Mateescu, M A 17 Mayall, S 10, 18 McCarthy, B J 34 Meglinski, I 34 Merlo, L 14 Merolli, A 27 Meyer, B K 9, 21 Miraftab, M 34 Mitra, A K 19 Miyazaki, S 32 Montano, M 15 Morris, P 35 Moulton, G G 7 Narayan, R 32, 36 Netti, P 23 Neves, N M 31 Niinomi, M 30 Nimesh, S 5 O’Neill, M 3, 12 Orgill, D P 28 Pan, J 35 Park, K 24 Patravale, V 16 Peake, B M 17 Peters, W 26 Phillips, G O 33, 40 Pignatello, R 19 Planell, J A 27 Poh, A-L 18 Poltronieri, P 2, 8 Prakash, S 40 Prokopovich, P 25 Qian, H 31

Kahol, K 15 Kang, L 18 Katoch, S 29 Kennedy, J F 33, 34, 40 King, M W 33 Kochhar, J S 18 Kokubo, T 32 Kumar, B 34 Kundu, S 23 Kwan, Y H 18

Rajendran, S 34 Ralphs, J 27 Ramalingam, P 6, 9 Ranganathan, S 4 Reis, R L 31 Reljanovic, M 11, 18 Revell, P A 22 Rimmer, S 33 Rodriguez, J 11, 13 Rogers, W 38 Roterman-Konieczna, I 4 Roy, J 18 Ruys, A J 31

Lacroix, D 27 Lai, L 19 Laurenzi, I 3 Lecca, P 3 Lerouge, S 38 Lewis, A 27 Li, R-K 23

Sahoo, U 13, 17, 21 Salih, V 25 Sandle, T 20 Sant, S 24 Santos, H A 30 Saraswathy, N 6, 9 Sawant, D 17

Sharma, C P 18, 38 Shimizu, K 9 Simmons, A 38 Smart, N J 11, 14 Sonia, T A 18 Stamboulis, A 38 Strohl, L M 9, 21 Strohl, W R 9, 21 Sundararajan, R 2, 15 Tanner, E 26 Tolias, P 32 Tong, J C 4 Trincone, A 8 Tung, Y K 18 Uchida, S 4, 6 Vadgama, P 37 Vallittu, P 37 Van Der Straeten, C 28 Van Langenhove, L 33 Vasudev, A 39 Vernon, B 33 Vlierberghe, S V 24 Walker, J 29 Watson, T F 27 Webster, T J 25, 26 Weisel, R D 23 Welty, G 6 Williams, D R 11 Williams, M A 16 Williams, P A 33, 40 Williams, R 40 Williams, S 12, 14 Wolf, C 26 Yan, Y 36 Ylänen, H O 33 Yoneyama, T 32 Young, V L 26 Zhao, X 31 Zhou, Y 36 Zhou, Y N 37

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