Essential Resources in
Pharmaceutical Science from CRC Press
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Contents Drug Development..................................................4 Drug Delivery ........................................................10 Drug Discovery......................................................13 Page 4
Page 12
Regulation Standards ............................................14 Manufacturing & Engineering ..............................15 Pharmacology & Toxicology ................................20
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Drug Development Generic Drug Product Development
Making and Using Antibodies
Solid Oral Dosage Forms, Second Edition
A Practical Handbook, Second Edition Edited by
Edited by
Gary C. Howard
Leon Shargel
The Gladstone Institutes, San Francisco, California, USA
Applied Biopharmaceutics, Raleigh, North Carolina, USA
Matthew R. Kaser
Isadore Kanfer
Bell & Associates, San Francisco, California, USA
Rhodes University, Grahamstown, South Africa
Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science—both for conventional immune response research as well as other areas related to protein identification analysis. This second edition of Making and Using Antibodies: A Practical Handbook provides clear guidance on all aspects of how to make and use antibodies for research along with their commercial and industrial applications.
Generic Drug Product Development: Solid Oral Dosage Forms presents in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products— including the availability of raw materials and chemical purity. The book outlines a variety of legal, regulatory, and patent challenges presented by the brand-name pharmaceutical industry. It describes scale up, postapproval changes, and post-marketing surveillance and details the ANDA regulatory process. This second edition contains chapters on experimental formulation development and the relationship between the FDA and the United States Pharmacopeia.
Selected Contents: Generic Drug Product Development and Therapeutic Equivalence Active Pharmaceutical Ingredients Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms Experimental Formulation Development Scale-up, Technology Transfer, and Process Performance Qualification Drug Stability Quality Control and Quality Assurance Drug Product Performance: In Vitro ANDA Regulatory Approval Process Bioequivalence and Drug Product Assessment: In Vivo Statistical Considerations for Establishing Bioequivalence Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing Index Catalog no. H8635, October 2013, 397 pp. ISBN: 978-1-4200-8635-5, $199.95 / £125.00 Also available as an eBook
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Keeping pace with new developments in this area, all chapters in this new edition have been revised, updated, or expanded. Along with discussions of current applications, new material in the book includes chapters on western blotting, aptamers, antibodies as therapeutics, quantitative production, and humanization of antibodies. The authors present clear descriptions of basic methods for making and using antibodies and supply detailed descriptions of basic laboratory techniques. Each chapter begins with introductory material, allowing for a better understanding of each concept, and practical examples are included to help readers grasp the real-world scenarios in which antibodies play a part. From the eradication of smallpox to combating cancer, antibodies present an attractive solution to a range of biomedical problems. They are relatively easy to make and use, have great flexibility in applications, and are cost effective for most labs. This volume will assist biomedical researchers and students and pave the way for future discovery of new methods for making and using antibodies for a host of applications.
Selected Contents: Antibodies. Antigens and Adjuvants. Production of Polyclonal Antibodies. Purification and Characterization of Antibodies. Production of Monoclonal Antibodies. Quantitative Production of Monoclonal Antibodies. Making Antibodies in Bacteria. Selection of Aptamers. Chemical and Proteolytic Modification of Antibodies. Western Blots and Other Applications. Immunohistochemical Methods. Immunoelectron Microscopy. Flow Cytometry. ELISAs. Humanization of Antibodies. ... Catalog no. K13167, July 2013, 458 pp., Soft Cover ISBN: 978-1-4398-6908-6, $149.95 / £95.00 Also available as an eBook
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Drug Development Pharmaceutical Formulation Development of Peptides and Proteins Second Edition Edited by
Drug Stereochemistry Analytical Methods and Pharmacology, Third Edition Edited by
Krzysztof Jozwiak
Lars Hovgaard
Medical University of Lublin, Poland
Novo Nordisk A/S, Malov, Denmark
W. J. Lough
Sven Frokjaer and Marco van de Weert
University of Sunderland, UK
University of Copenhagen, Denmark
Irving W. Wainer
The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.
National Institute of Health, Bethesda, Maryland, USA
Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: • The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology • The physicochemical characteristics and stability of peptides and proteins • The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids • The opportunities and challenges of nonparenteral delivery of peptides and proteins • Risk factors, specifically the development of an unwanted immune response • A simulation approach to describe the fate of peptides and proteins upon administration to a biological system • The documentation required to register a protein-based drug
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology.
Topics include: • The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery • How stereochemistry impacts decisions made in the absorption, distribution, metabolism, excretion, and toxicity (ADMET) stages of drug discovery • Pharmacokinetics and pharmacodynamics and the issues faced during the final stages of the drug development process • The impact of the International Conference on Harmonisation (ICH) on the use of single isomer drugs • Chiral switches • The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs • Patent issues surrounding chiral switches and the marketing of single enantiomer switches
Selected Contents:
Selected Contents:
Peptide Synthesis Protein Expression Protein Purification Characterization of Therapeutic Peptides and Proteins Chemical Pathways of Peptide and Protein Degradation Physical Instability of Peptides and Proteins Peptide and Protein Derivatives Peptides and Proteins as Parenteral Solutions Peptides and Proteins as Parenteral Suspensions Rational Design of Solid Protein Formulations ...
Introduction. The Separation, Preparation and Identification of Stereochemically Pure Drugs: Indirect Methods for the Chromatographic Resolution of Drug Enantiomers: Synthesis and Separation of Diastereo-Metric Derivatives. The Direct Resolution of Enantiometric Drugs by Chiral Phase Gas Chromatography. Enantioselective Separations by Capillary Electrophoresis. Recent Advances in the Synthesis of Enantiomerically Pure Compounds. Production Scale Preparation of Enantiomerically Pure Compounds by Chromatography and Synthetic Approaches.
Catalog no. K12494, November 2012, 392 pp. ISBN: 978-1-4398-5388-7, $169.95 / £104.00 Also available as an eBook
Catalog no. H9238, April 2012, 332 pp. ISBN: 978-1-4200-9238-7, $159.95 / £99.00 Also available as an eBook
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Drug Development Pharmacogenomics of Alcohol and Drugs of Abuse
Safety Pharmacology in Pharmaceutical Development
Edited by
Approval and Post Marketing Surveillance, Second Edition
Amitava Dasgupta University of Texas, Houston, USA
Loralie J. Langman
Shayne C. Gad
Mayo Clinic, Rochester, Minnesota, USA
Gad Consulting Services, Cary, North Carolina, USA
Pharmacogenomics is the basis of personalized medicine, which is said to be the medicine of the future. Understanding genetic variation in drug and alcohol response is vital for professionals working in rehabilitation programs. The same principles that are applicable for therapeutic drugs are also applicable for drugs of abuse. Pharmacogenomics can supplement traditional therapeutic drug monitoring, potentially predicting correct dosage before initiation of the drug therapy. Applying these principles to testing and treatment, Pharmacogenomics of Alcohol and Drugs of Abuse discusses the role of the clinical laboratory in the practice of personalized medicine. With contributions from a range of experts, the book presents the genetic aspects of alcohol metabolism and other drugs including marijuana, cocaine, and amphetamines. In addition to basic pharmacogenomic aspects, the book addresses slate and trait markers of drugs of abuse so readers can consider setting appropriate biomarker tests in their clinical laboratory.
Selected Contents: Pharmacogenomics Principles and Molecular Mechanism of Action of Alcohol and Abused Drugs Alcohol: Use and Abuse
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions. Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, it incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.
Selected Contents:
Slate and Trait Markers of Alcohol Abuse
Safety Pharmacology: Background, History, Issues, and Concerns
Genetic Aspect of Alcohol Metabolism and Abuse
Regulatory Requirements: ICH, FDA, EMA, and Japan
Introduction to Drug Abuse
Regulatory Requirements
Pharmacogenomics of Amphetamine and Related Drugs
Principles of Screening and Study Design
Genetic Aspect of Cocaine Metabolism and Abuse Genetic Aspect of Marijuana Metabolism and Abuse Genetic Aspect of Opiate Metabolism and Addiction Pharmacogenomics Aspect of Addiction Treatment Methodologies in Pharmacogenomics Testing Catalog no. K12633, April 2012, 252 pp. ISBN: 978-1-4398-5611-6, $159.95 / £100.00 Also available as an eBook
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Cardiovascular System Central Nervous System Respiratory System Renal Function The Gastrointestinal System The Immune System Catalog no. K12039, April 2012, 213 pp. ISBN: 978-1-4398-4567-7, $159.95 / £100.00 Also available as an eBook
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Drug Development Pharmaceutical Stress Testing
Generic Drug Product Development
Predicting Drug Degradation, Second Edition
Specialty Dosage Forms
Edited by
Leon Shargel
Steven W. Baertschi
Applied Biopharmaceutics, Raleigh, North Carolina, USA
Eli Lilly & Company, Indianapolis, Indiana, USA
Isadore Kanfer
Karen M. Alsante Pfizer Global R&D, Groton, Connecticut, USA
Robert A. Reed Celsion Corporation, Columbia, Maryland, USA
“The authors and editor have done a superb job of combining the theoretical, chemical, and practical aspects of stress testing … the text is a 'must have' for those involved in stability testing.” —Drug Development and Industrial Pharmacy
“This excellent reference on pharmaceutical stress testing will serve its purpose well, especially for pharmaceutical product development scientists and for members of regulatory agencies who are actively involved in the drug review and approval process.” —Doody's Review Service
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing, and interpreting stress testing studies for drug products. The book expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It contains updated methodologies for predicting drug stability and degradation pathways, best practice models to follow, and a useful Frequently Asked Questions section.
Rhodes University, Grahamstown, South Africa
“This is a must for pharmaceutical researchers who are involved in developing generic specialty products with proven bioequivalence.” —Doody's Book Review Service
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products. Generic biologics and modified release parenteral drug products are also covered. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.
Contents:
The Chemistry of Drug Degradation. Relation to the Development Timeline. Oxidative Susceptibility Testing. Practical Aspects of Conducting Photostability Stress Testing. Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening. Stability Considerations in Development of Freeze Dried Pharmaceuticals. Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes or Materials from Multiple Sources. The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals. Use of Automation in Conducting Stress Testing and Excipient Compatibility Studies. The Use of Microcalorimetry in Stress Testing. Stress Testing as it Relates to Shipping / Distribution - Real World Measurements and Implications. Stress Testing: Frequently Asked Questions.
Introduction, Leon Shargel Nonsystemically Absorbed Oral Drug Products Topical Drug Products—Development, Manufacture and Regulatory Issues Assessment of Topical Dosage Forms Intended for Local or Regional Activity Rectal Dosage Forms and Suppositories Nasal and Inhalation Drug Products Locally Acting Nasal and Inhalation Drug Products: Regulatory and Bioequivalence Perspective Transdermal Dosage Forms Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vivo Correlation (IVIVC) Principles Biosimilar Drug Products—Manufacture and Quality Index
Catalog no. H100006, July 2011, 612 pp. ISBN: 978-1-4398-0179-6, $199.95 / £127.00 Also available as an eBook
Catalog no. DK7786, March 2010, 288 pp. ISBN: 978-0-8493-7786-0, $159.95 / £99.00 Also available as an eBook
Selected Contents:
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Drug Development Active Pharmaceutical Ingredients Development, Manufacturing, and Regulation, Second Edition
Pharmaceutical Statistics Practical and Clinical Applications, Fifth Edition Sanford Bolton Creskill, New Jersey, USA
Edited by
Charles Bon
Stanley Nusim
Biostudies Solutions, LLC, Wilmington, North Carolina, USA
S.H. Nusim & Associates, Inc., Aventura, Florida, USA
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally.
Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.
This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.
• Includes step-by-step examples for analyzing text examples using common software programs • Covers the in vitro–in vivo correlation, and how it can be used in the drug development process to improve FDA acceptance of post-approval manufacturing changes • Discusses adaptive designs in clinical research and advanced statistical designs in clinical trials with safety/efficacy endpoints • Explains one- and two-sided statistical tests • Covers interim and sequential analysis for clinical trials and bioequivalence studies • Discusses assumptions and applications of nonparametric methods • Includes the application of confidence intervals for a ratio based on Fieller’s Theorem • Expands on the concepts of multiple and logistic regression • Provides tables in the appendix to clarify material
Selected Contents:
Contents:
Topics include: • Safety, efficacy, and environmental/regulatory requirements • Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China • The FDA’s intensified foreign inspection program • Multi-use and flexible design facilities • The shift from maintenance scheduling to built-in reliability
Introduction Process Development, Scaleup, and Design Technology Transfer and First Manufacture Plant Design and Construction Regulatory Requirements: US Regulatory Requirements: Outside US Process Validation Quality Assurance and Control Environmental Control Safety Plant Operations Bulk Sterile Manufacturing Materials Management Plant Maintenance
Basic Definitions and Concepts Data Graphics Introduction to Probability: The Binomial and Normal Probability Distributions Choosing Samples Statistical Inference: Estimation and Hypothesis Sample Size and Power Linear Regression and Correlation Analysis of Variance Factorial Designs Transformations and Outliers Experimental Design in Clinical Trials Quality Control Validation Computer-Intensive Methods Nonparametric Methods Optimization Techniques and Screening Designs
Catalog no. H100022, December 2009, 320 pp. ISBN: 978-1-4398-0336-3, $179.95 / £114.00 Also available as an eBook
Catalog no. H7422, December 2009, 670 pp. ISBN: 978-1-4200-7422-2, $189.95 / £121.00 Also available as an eBook
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Drug Development Approaches to the Conformational Analysis of Biopharmaceuticals Roger L. Lundblad
Biodrug Delivery Systems Fundamentals, Applications and Clinical Development
Lundblad Biotechnology, Chapel Hill, North Carolina, USA
Edited by
“Without any hesitation, I recommend this book to any researcher involved in the analysis of conformation and stability of biotechnology products (not necessarily limited to biopharmaceuticals).”
Hoshi University, Tokyo, Japan
—Igor A Kaltashov, in Future Science
Conformational analysis is becoming more critical in the development of generic biopharmaceuticals. Approaches to the Conformational Analysis of Biopharmaceuticals describes methods used to establish comparability between potentially identical products, providing researchers with a critical description of studies drawn from the current literature. The text covers physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation, as well as chemical methods, including hydrogen–deuterium exchange and trace labeling. The author shows how these methods support comparability claims for generic biologicals and assure structural integrity of active pharmaceutical ingredients in final drug products.
Selected Contents: Comparability of Biotechnological/Biological Products and Biological Generics Application of Native Electrophoresis for the Study of Protein Conformation Chromatography in the Study of Biopolymer Conformation Size-Exclusion Chromatography and Biomolecular Conformation Light Scattering and Biomacromolecular Conformation Near-Infrared Spectroscopy and Macromolecular Conformation Use of Raman Spectroscopy to Evaluate Biopharmaceutical Conformation Use of UV-VIS Spectrophotometry for the Characterization of Biopharmaceutical Products Use of Optical Rotatory Dispersion and Circular Dichroism to Study Therapeutic Biomacromolecule Conformation Use of Nuclear Magnetic Resonance for the Characterization of Biotherapeutic Products Use of Chemical Probes for the Study of Protein Conformation Use of Hydrogen Exchange in the Study of Biopharmaceutical Conformation ... Catalog no. K10401, December 2009, 366 pp. ISBN: 978-1-4398-0780-4, $179.95 / £112.00 Also available as an eBook
Mariko Morishita Kinam Park Purdue University, West Lafayette, Indiana, USA
Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science that discusses the latest advances in biodrug delivery systems and associated techniques. The book discusses components of successful formulation, delivery, and production of biodrugs, including plant and process design, a well-trained and knowledgeable staff, and proper quality control. In addition, the authors examine: • ADME (Absorption, Metabolism, Distribution, and Elimination of biodrugs) • Directing and influencing the successful development of currently marketed best-selling biodrugs • Routes of administration • Mechanisms of biodrug absorption • Alternative possibilities for drug delivery routes • Formulations on the market from the perspective of industry personnel involved in biodrug development
Selected Contents: Overview of Biodrug Delivery System Issues in Biodrug Delivery System Pharmacokinetic Consideration of Biodrugs Specific Route of Delivery Parenteral Delivery Brain Delivery Ocular Delivery Nasal Delivery Buccal Delivery Pulmonary Delivery Transdermal Delivery Colon Delivery Oral Delivery Cellular Delivery Delivery Systems Targeting: PK Consideration Monoclonal Antibody Receptor-Mediated Endocytosis... Catalog no. H8668, December 2009, 488 pp. ISBN: 978-1-4200-8668-3, $179.95 / £114.00 Also available as an eBook
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Drug Delivery
Role of Lipid Mediators
Pharmaceutical Dosage Forms and Drug Delivery
Edited by
Second Edition
Abhijit Ray and Punit Kumar Srivastava
Ram I. Mahato
Obstructive Airway Diseases
Daiichi Sankyo Life Science Research Centre India (RCI), Gurgaon, Haryana
Ajit S. Narang
Incidences of inflammatory airway diseases are on the rise across the world and it is imperative that research be undertaken to discover new treatment options. Obstructive Airway Diseases: Role of Lipid Mediators discusses clinically successful and potential lipid targets that can make a difference in treating some of the most intractable disease states.
Topics discussed include: • Obstructive airway diseases, etiology, pathophysiology, and existing therapeutic options • What constitutes a lipid and how it is broken down to generate biologically active mediators • The role of enzymes in the process of lipid mediator synthesis • The biology of arachidonic acid, plateletactivating factor, and lysophosphatidic acid and the roles they play in airway inflammation • Products of arachidonic acid metabolism such as leukotrienes, prostaglandins, epieicosatrienoic acid, and oxoeicosatetraenoic acid • Proresolution lipid mediators in inflammatory airway disease conditions • The roles of sphingosine and ceramide in inflammatory airway disease • Protein kinases activated by lipid mediators and those that trigger the generation of lipid messengers
Selected Contents: Obstructive Airway Diseases: Epidemiology, Etiology, and Therapeutic Options. Lipids: Reservoir of Drug Targets. Phospholipase A2 as a Potential Drug Target for Airway Disorders. Leukotriene Receptor Antagonists and FLAP Inhibitors. EETs and Oxo-ETE in Airway Diseases. The Eosinophil Chemoattractant 5-Oxo-ET. Cyclooxygenases and Prostaglandin Receptors. Platelet-Activating Factor Antagonist Therapy for Airway Disorders. Lysophosphatidic Acid in Airway Inflammation. Sphingolipids in Airway Inflammation. Prospects for PI3 Kinase Signaling Inhibition in Obstructive Airway Diseases. Catalog no. K12353, November 2011, 381 pp. ISBN: 978-1-4398-5140-1, $179.95 / £112.00 Also available as an eBook
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University of Nebraska Medical Center, Omaha, USA Bristol-Myers Squibb, Co., New Brunswick, New Jersey, USA
“Containing the right blend of mathematics, equations, diagrams, pictorials, and other pertinent information, this book provides a unified perspective that creates a greater overall understanding of basic science and cutting-edge technology.” —Anticancer Research
In the second edition of Pharmaceutical Dosage Forms and Drug Delivery, the authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field.
Highlights of the Second Edition: • Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules • Reorganized into three parts: Introduction, Physicochemical Principles, and Dosage Forms • Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles • Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter • Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approach to the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals. Catalog no. K12224, October 2011, 512 pp. ISBN: 978-1-4398-4918-7, $125.95 / £84.00 Also available as an eBook
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Drug Delivery Drug Delivery Systems Third Edition Vasant V. Ranade Academic Pharmaceuticals Inc, Lake Bluff, Illinois, USA
John B. Cannon Targeted Drug Solutions, Grayslake, Illinois, USA
Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody–directed delivery. Each chapter presents a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors offer a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.
Contents: Site-Specific Drug Delivery Using Liposomes and Emulsions as Carriers Site-Specific Drug Delivery Utilizing Monoclonal Antibodies Role of Polymers in Drug Delivery Implants in Drug Delivery Oral Drug Delivery Enhancing Oral Bioavailability Transdermal Drug Delivery Transmucosal and Ocular Drug Delivery Miscellaneous Forms of Drug Delivery Nanoscience and Nanotechnology for Drug Delivery Regulatory Considerations for Drug Delivery Systems Drug Delivery Industry and the Global Outlook Catalog no. K10307, April 2011, 608 pp. ISBN: 978-1-4398-0618-0, $220.00 / £141.00 Also available as an eBook
Targeted Delivery of Small and Macromolecular Drugs Edited by
Ajit S. Narang Bristol-Myers Squibb, Co., New Brunswick, New Jersey, USA
Ram I. Mahato University of Tennessee Health Science Center, Memphis, USA
Site-specific drug delivery and targeting attracts much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Focusing on the delivery technologies that utilize both systemic and local routes of administration, Targeted Delivery of Small and Macromolecular Drugs brings together field experts who summarize current progress and discuss novel ideas currently being explored to overcome these challenges. The contributors discuss the most promising strategies for drug targeting and also examine targeted drug delivery platforms and technologies at various stages of clinical and preclinical development, including: • • • • • • •
Active targeting Nucleic acid delivery and targeting Intracellular/organelle-specific strategies Prodrug strategies Organ or tissue-specific drug delivery Drug-polymer conjugates and micelles Stimuli-responsive systems
Selected Contents: Active Targeting Antibody Therapies for Liver Malignancy and Transplantation Ionizing Radiation for Tumor-Targeted Drug Delivery Nucleic Acid Delivery And Targeting Recent Advances in Gene Expression and Delivery Systems Targeted Delivery Systems of Nonviral Nucleic Acid–Based Therapeutics Intracellular/Organelle-Part Specific Strategies Mitochondria-Targeted Drug Delivery Prodrug Strategies Site-Specific Prodrug Activation Strategies for Targeted Drug Action Enzyme-Activated Prodrug Strategies for Targeted Drug Action Organ- Or Tissue-Specific Drug Delivery... Catalog no. 8772X, May 2010, 630 pp. ISBN: 978-1-4200-8772-7, $115.95 / £72.99 Also available as an eBook
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Drug Delivery Oral Drug Absorption
Ocular Drug Delivery Systems
Prediction and Assessment, Second Edition Edited by
Barriers and Application of Nanoparticulate Systems
Jennifer B. Dressman
Edited by
Johann Wolfgang Goethe University, Frankfurt, Germany
Christos Reppas
Deepak Thassu Actavis SSL R&D, Owings Mills, Maryland, USA
National and Kapodistrian University of Athens, Greece
Gerald J. Chader
Oral Drug Absorption, Prediction and Assessment, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR and IR formulations.
University of Southern California Medical School, Doheny Eye Institute, Los Angeles, USA
This practical, hands-on guide includes an interactive CD that helps pharmaceutical industry personnel model their own testing data. They will learn how to identify formulations that will produce the best clinical results and verify batch-to-batch reproducibility. They will also understand how to identify whether changes in formulation or manufacturing procedure after marketing approval affect clinical performance, and how to determine if a generic version of the medicine can be approved This edition includes information about bioequivalence studies, biowaiving, formulation screening, and different approaches from U.S. industry and European industry perspectives. It also reviews major advances in pharmacokinetic modeling and profiling. Casebased examples are included to clarify the material.
Selected Contents: Physiology of Oral Drug Absorption Physiological Factors Affecting Drug Release and Absorption in the Gastrointestinal Tract Food Effects on Drug Absorption and Dosage Form Performance Oral Drug Absorption in Pediatric Populations Gastrointestinal Disease and Dosage Form Performance The Biopharmaceutics Classification System Drug Solubility in the Gastrointestinal Tract Permeability Measurement Nonclinical Methods to Evaluate Oral Formulations Modified-Release Dosage Forms: Formulation Screening in the Pharmaceutical Industry Immediate Release Oral Dosage Forms: Formulation Screening in the Pharmaceutical Industry Computer Models for Predicting Drug Absorption Bioequivalence Studies In Vivo Bioequivalence Assessment Biowaiving Based on the BCS—A Global Comparison Catalog no. H7733, March 2010, 450 pp. ISBN: 978-1-4200-7733-9, $159.95 / £99.00 Also available as an eBook
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Drug discovery for ocular diseases has taken great strides in the last two decades. From cornea to choroid, new drugs have been formulated to address a great variety of ocular diseases. Yet without good drug delivery systems, these drugs are less effective than they might be or could even cause serious side effects. Ocular Drug Delivery Systems: Barriers and Application of Nanoparticulate Systems presents research on the development of currently marketed devices and recent trends in the topical delivery of drugs to the posterior of the eye. With contributions from leading pharmaceutical researchers and industry experts, eye researchers, surgeons, pharmacologists from academia, the National Eye Institute, and leading ophthalmic companies such as Pfizer, Allergan, and Novartis, it presents the state of the art in the use of nanoparticles in ocular drug delivery systems and also sets the stage for future developments. The book provides both a current evaluation and a future roadmap for developments in ocular drug delivery. The subjects range from biological needs to material challenges and finally to clinical applications for improving drug delivery for conditions where treatments already exist. It also explores areas where effective drugs may be currently available but yet need a safe, efficient, and efficacious delivery vehicle.
Selected Contents: Basic Considerations Eye Anatomy, Physiology and Ocular Barriers: Basic Considerations for Drug Delivery Computer Modeling for Ocular Drug Delivery Challenges in the Development of NanotechnologyBased Ophthalmic Systems Ocular Barriers Blood–Retinal Barrier: The Fundamentals Barriers to Transscleral Drug Delivery to the Retina Ocular Compartment Drug Delivery Drug Delivery to the Vitreous Humor Transscleral and Suprachoroidal Drug Delivery Protein Drug Delivery to Retina and Choroid Drug Delivery Systems... Catalog no. K12138, October 2012, 473 pp. ISBN: 978-1-4398-4800-5, $179.95 / £113.00 Also available as an eBook
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Drug Discovery Applying Genomic and Proteomic Microarray Technology in Drug Discovery
Pharmaceutical Dosage Forms
Second Edition
Edited by
Robert S. Matson
Sandeep Nema and John D. Ludwig
QuantiScientifics, LLC, Irvine, California, USA
Microarrays play an increasingly significant role in drug discovery. The commercial landscape has changed dramatically over the past few years and researchers have made great advances with regard to construction and use. Now in its second edition, Applying Genomic and Proteomic Microarray Technology in Drug Discovery highlights, describes, and evaluates current scientific research using microarray technology in genomic and proteomic applications.
Revised to reflect recent progress in the field, the second edition discusses: • Expanded omics-driven applications, including the areas of metabolomics and chemical biology • The commercialization of the microarray platform, with a historical perspective aimed at recognizing key technological developments • Solid-supports (substrates) and surface chemistries currently used in the creation of nucleic acid and protein microarrays • Different approaches to producing microarrays that achieve spot equality with the same number of molecules properly oriented • The development of the gene expression microarray and representative applications • The development of protein microarray technology, including its history and key applications Unique to this edition is a chapter on multiplex assays that examines the development and applications of arrays across diverse platforms. It discusses applications for qPCR, multiplex lateral flow, and multiplex bead assays. It also presents platform-to-platform comparisons.
Contents: Omics and Microarrays Revisited. Commercial Microarrays. Supports and Surface Chemistries. Arraying Processes. Gene Expression: MicroarrayBased Applications. Protein Microarray Applications. Multiplex Assays. Index. Catalog no. K12595, March 2013, 322 pp. ISBN: 978-1-4398-5563-8, $149.95 / £95.00 Also available as an eBook
Parenteral Medications Third Edition Three-Volume Set
Pfizer R&D, Chesterfield, Missouri, USA
Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Volume 1 (Formulation and Packaging) presents a historical perspective of injectable drug therapy. It discusses common routes of administration and biopharmaceutics of NCEs and NBEs. It examines the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. The book also presents a range of parenteral primary packaging options— including glass and plastic containers and elastomeric closures—and discusses container-closure integrity. This edition includes chapters on solubility and solubilization, formulation of depot delivery systems, and biophysical/biochemical characterization of proteins. Volume 2 (Facility Design, Sterilization and Processing) explores aseptic facility design, environmental monitoring, and cleanroom operations. It discusses pharmaceutical water systems and quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. The book contains a detailed discussion on the processing of parenteral drug products (SVPs and LVPs) as well as widely used sterilization technologies such as steam, gas/chemical, radiation, filtration, and dry heat. It also examines lyophilization. Volume 3 (Regulations, Validation and the Future) provides an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. The book covers recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), as well as validation of drug product manufacturing process. Each individual volume is also available separately. See pages 14 and 17 to purchase the individual volumes
Catalog no. H8653, August 2010 ISBN: 978-1-4200-8653-9, $399.95 / £254.00
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13
Regulation Standards New!
FDA Regulatory Affairs Third Edition Edited by
Douglas J. Pisano and David Mantus Massachusetts College of Pharmacy & Health Sciences, Boston, USA
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the U.S. Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.
The Third Edition of this highly successful publication: • Examines the harmonization of the U.S. Federal Food, Drug, and Cosmetic Act with international regulations • Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL
Pharmaceutical Dosage Forms Parenteral Medications, Third Edition Volume 3: Regulations, Validation and the Future, Third Edition Edited by
Sandeep Nema and John D. Ludwig Pfizer R&D, Chesterfield, Missouri, USA
Regulations, Validation and the Future is the third volume in the Pharmaceutical Dosage Forms: Parenteral Medications three-volume set. The book provides an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. The book covers recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), as well as validation of drug product manufacturing process.
• Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding requirements
Contents:
• Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines
Risk Assessment and Mitigation in Aseptic Processing
• Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions
Visual Inspection
Selected Contents:
CGMP Regulations of Parenteral Drugs Validation of Drug Product Manufacturing Processes: NCEs and NBEs Advances in Parenteral Injection Devices and Aids SiRNA Targeting Using Injectable Nano-based Delivery Systems
Overview of FDA and Drug Development. What Is an IND? The New Drug Application. Meetings with the FDA. FDA Medical Device Regulation. A Primer of Drug/Device Law: What Is the Law and How Do I Find It? The Development of Orphan Drugs. CMC Sections of Regulatory Filings and CMC Regulatory Compliance during Investigational and Postapproval Stages. Overview of the GxPs for the Regulatory Professional. FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices. The Practice of Regulatory Affairs. FDA Advisory Committees. Biologics. Regulation of Combination Products in the United States.
Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls
Catalog no. H100295, February 2014, 400 pp. ISBN: 978-1-84184-919-5, $159.95 / £99.00 Also available as an eBook
Future of Parenteral Manufacturing
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Techniques to Evaluate Damage and Pain on Injection Parenteral Product Specifications and Stability Extractables and Leachables Process Analytical Technology and Rapid Microbial Methods Quality Assurance Application of Quality by Design in CMC Development Catalog no. H8647, August 2010, 318 pp. ISBN: 978-1-4200-8647-8, $159.95 / £99.00 Also available as an eBook
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Manufacturing & Engineering Dietary Supplement Good Manufacturing Practices
Bestseller!
Encyclopedia of Pharmaceutical Science and Technology
Preparing for Compliance
Fourth Edition, Six-Volume Set
William J. Mead
Edited by
Rowayton, Connecticut, USA
James Swarbrick
“ … a useful tool to further the implementation of more ‘modern’ approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory standpoint.”
PharmaceuTech, Inc, Pinehurst, North Carolina, USA
“ … sets the standard in the field … like having a pharmaceutical library at your fingertips, notable for providing answers to the latest questions in a fascinating field of study.” —Electric Review
“ … a valuable resource … a good reference for people who work in the pharmaceutical sciences… includes in-depth articles, which are all referenced.” —Doody's Review Service
The Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition is a must-have reference guide for all laboratories and libraries in the pharmaceutical field. Bringing together leaders from every specialty related to pharmaceutical science and technology, this is the single-source reference at the forefront of pharmaceutical R&D. The fourth edition offers 29 chapters ranging from biomarkers, computational chemistry, and contamination control to high-throughput screening, orally disintegrating tablets, and quality by design. The encyclopedia details best practices for equipment used, methods for manufacturing, options for packaging, and routes for drug delivery. The volumes also provide a thorough understanding of the choices behind each method. Regulations, safety aspects, patent guidance, and methods of analysis are included.
Key Areas Covered: • • • • • • • • • • •
Analytics Biomarkers Dosage forms Drug delivery Formulation Informatics Manufacturing Packaging Processing Regulatory affairs Systems validation
Catalog no. H100233, July 2013, 4296 pp. ISBN: 978-1-84184-819-8, $2999.00 / £1800.00
—Elena Vittadini, International Journal of Food Science and Nutrition
“ … should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA’s lengthy regulations and preamble, making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only ‘what’ the rule requires but ‘how’ to comply, and ‘why’ each topic is critical to pass your next inspection. Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door.” —Steve Mister, President & CEO, Council for Responsible Nutrition
Dietary Supplement Good Manufacturing Processes is a one-stop “how-to” road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations outline broad goals but intentionally avoid specifics to allow for future technological advances—leaving implementation to the discretion of each firm. Given this latitude and flexibility, this resource is an essential guide to workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, the book is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory. • Provides practical guidance in easy-to-understand language to help navigate through the requirements for systems covering process and quality control • Includes suggestions and practical recommendations on how-to achieve full compliance • Explains the FDA’s role regarding inspection, enforcement, recall/seizure of products, and prosecution Catalog no. H7740, November 2011, 312 pp. ISBN: 978-1-4200-7740-7, $159.95 / £99.00 Also available as an eBook
For more information and complete contents, visit www.crcpress.com
15
Manufacturing & Engineering Pharmaceutical Powder Compaction Technology Second Edition Edited by
System Design, Operation, and Validation, Second Edition William V. Collentro
Metin Çelik Pharmaceutical Technologies International, Belle Mead, New Jersey, USA
Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application.
This unique reference covers: • The physical structure of pharmaceutical compacts • Bonding phenomena that occur during powder compaction • Compression mechanisms of pharmaceutical particles • Theories and basic principles of powder compaction
Topics include: • Compaction data analysis techniques • The migration of powder constituents into commercial manufacture • Instrumentation for compaction • Compaction functionality testing, which is likely to become a USP requirement • Design space for compaction • Metrics required for scalability in tablet compression • Interactive compaction and preformulation database for commonly used excipients
Selected Contents: Theory of Compaction: Intermolecular Bonding Forces: where materials and process come together. Compaction Data Analysis Techniques: Viscoelastic Models. Application of Percolation Theory and Fractal Geometry to Tablet Compaction. Post Compaction Data Analysis Techniques. Instrumentation and Equipment in Compaction: Tablet Press Instrumentation in the Research and Development Environment. Advanced Compaction Research Equipment: Compaction Simulators. Compactability Functionality Test. ... Catalog no. H8917, August 2011, 344 pp. ISBN: 978-1-4200-8917-2, $159.95 / £99.00 Also available as an eBook
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Pharmaceutical Water
Plymouth, Massachusetts, USA
“This second edition has been significantly revised and updated from the first edition. The author's extensive work experience in this field is reflected throughout the book, which will serve as an excellent reference for anyone involved in manufacturing pharmaceutical waters.” —Doody's Review Service
Water is the most used raw material ingredient in the pharmaceutical and biotechnology industries. Drawing on the author’s extensive field experience with more than 400 pharmaceutical and related water purification systems, this volume provides numerous case studies to illuminate the best and worst of water system design and operation. Topics include passivation and electropolishing, rouging, ozone systems and accessories, USP purified water and water for injection, and individual component process and instrumentation diagram (P&IDs) with control interface. The book also examines documentation and specification requirements and systems installation, start-up, and commissioning.
Contents: Introduction Impurities in raw water Pretreatment techniques Ion removal techniques—reverse osmosis Ion removal techniques—ion exchange Additional ion removal techniques Distillation and Pure Steam generation Storage systems and accessories Ozone systems and accessories Polishing components Distribution systems—design, installation, and material selection Controls and instrumentation System design and specification guidelines System installation, start-up, and commissioning System validation Catalog no. H7782, December 2010, 478 pp. ISBN: 978-1-4200-7782-7, $159.95 / £99.00 Also available as an eBook
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Manufacturing & Engineering Pharmaceutical Dosage Forms Parenteral Medications, Third Edition Volume 1: Formulation and Packaging Edited by
Sandeep Nema and John D. Ludwig Volume 1 (Formulation and Packaging) of this threevolume set presents a historical perspective of injectable drug therapy. It discusses common routes of administration and biopharmaceutics of NCEs and NBEs. It examines the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. The book also presents a range of parenteral primary packaging options—including glass and plastic containers and elastomeric closures—and discusses container-closure integrity. This edition includes chapters on solubility and solubilization, formulation of depot delivery systems, and biophysical/biochemical characterization of proteins. Catalog no. H8643, August 2010, 420 pp. ISBN: 978-1-4200-8643-0, $159.95 / £99.00 Also available as an eBook
Pharmaceutical Dosage Forms Parenteral Medications, Third Edition Volume 2: Facility Design, Sterilization and Processing Edited by
Sandeep Nema and John D. Ludwig Volume 2 (Facility Design, Sterilization and Processing) of this three-volume set explores aseptic facility design, environmental monitoring, and cleanroom operations. It discusses pharmaceutical water systems and quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. The book contains a detailed discussion on the processing of parenteral drug products (SVPs and LVPs) as well as widely used sterilization technologies such as steam, gas/chemical, radiation, filtration, and dry heat. It also examines lyophilization. Catalog no. H8645, August 2010, c. 406 pp. ISBN: 978-1-4200-8645-4, $159.95 / £99.00 Also available as an eBook
See page 13 to purchase the three-volume.
Freeze-Drying/ Lyophilization of Pharmaceutical and Biological Products Third Edition Edited by
Louis Rey AERIAL, Illkirch, France Cabinet d'Etudes, Lausanne, Switzerland
Joan C. May Mount Airy, Maryland, USA
Freeze-drying, or lyophilization, is a well-established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. Freeze Drying / Lyophilization of Pharmaceutical and Biological Products, Third Edition presents emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze-drying technology.
Selected Contents: Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures Structural and Dynamic Properties of Bulk and Confined Water Freezing and Annealing Phenomena in Lyophilization The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives Formulation Characterization Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture Freeze-Drying of Biological Standards Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material Pharmaceutical Packaging for Lyophilization Applications Closure and Container Considerations in Lyophilization Extractables and Leachables as Container Closure Considerations in Lyophilization... Catalog no. H100116, June 2010, 578 pp. ISBN: 978-1-4398-2575-4, $179.95 / £114.00 Also available as an eBook
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Manufacturing & Engineering Handbook of Pharmaceutical Manufacturing Formulations
Handbook of Pharmaceutical Manufacturing Formulations
Second Edition Volume One, Compressed Solid Products
Second Edition Volume Three, Liquid Products
Sarfaraz K. Niazi
Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
Sarfaraz K. Niazi
Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
Compressed solids are the largest category of pharmaceutical formulations, comprising almost two thirds of all dosage forms. They present some of the greatest challenges to formulation scientists. The first volume in the Handbook of Pharmaceutical Manufacturing Formulations discusses formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition. Topics include bioequivalence testing rationale and principles, testing protocols, the GMP audit template, EU guidelines, and guidance on formulating compressed solids. Catalog no. H8116, September 2009, 648 pp. ISBN: 978-1-4200-8116-9, $199.95 / £127.00 Also available as an eBook
Handbook of Pharmaceutical Manufacturing Formulations
While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Volume Three of the Handbook of Pharmaceutical Manufacturing Formulations, Second Edition presents practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing. It delineates things an FDA auditor will look for during a liquid manufacturing audit, issues that may arise during a US FDA inspection, and the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines.
Selected Contents:
Providing methodologies that can serve as a reference point for new formulations, this volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products. It explores regulatory and manufacturing guidelines, registration of pharmaceuticals for human use, process validation, bioequivalence regulatory review process and audit, and preapproval inspections. Additional topics include formulation factors in uncompressed dosage forms, dissolution testing of uncompressed solid dosage forms, approved excipients in uncompressed solid dosage forms, and uncompressed solids formulations.
Regulatory and Manufacturing Guidance Manufacturing Practice Considerations in Liquid Formulations Oral Solutions and Suspensions The FDA Drug Product Surveillance Program Changes to Approved NDAs and aNDAs Formulation Considerations of Liquid Products Container Closure Systems Stability Testing of New Drug Substances and Products Stability Testing: Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Evaluations of Stability Data Stability Data Package for Registration Applications in Climatic Zones III and IV EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use EDQM Certification Impurities: Guideline for Residual Solvents Electronic Records and Signatures [CFR 21 Part 11 Compliance] GMP Audit Template, EU Guidelines Bioequivalence Testing Protocols Dissolution Testing of Liquid Dosage Forms ...
Catalog no. H8118, September 2009, 392 pp. ISBN: 978-1-4200-8118-3, $199.95 / £127.00 Also available as an eBook
Catalog no. H8123, September 2009, 400 pp. ISBN: 978-1-4200-8123-7, $199.95 / £127.00 Also available as an eBook
Second Edition Volume Two, Uncompressed Solid Products Sarfaraz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
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Manufacturing & Engineering Handbook of Pharmaceutical Manufacturing Formulations
Handbook of Pharmaceutical Manufacturing Formulations
Second Edition Volume Four, Semisolid Products
Second Edition, Volume Five, Over-the-Counter Products
Sarfaraz K. Niazi
Sarfaraz K. Niazi
Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in semisolid products. Volume Four of the Handbook of Pharmaceutical Manufacturing Formulations covers the techniques and technologies involved in the preparation of products such as ointments, creams, gels, suppositories, and special topical dosage forms.
Contents: Regulatory and Manufacturing Guidance Waiver of In Vivo Bioequivalence Study Quality Risk Management Pharmaceutical Quality System Pharmaceutical Development Pharmaceutical Development in Ctd Scale-Up and Post-Approval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Validation of Analytical Procedures Good Manufacturing Requirements for Active Pharmaceutical Ingredients FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products Impurities In New Drug Substances Drug Products Impurities in New Drug Substances Formulation Factors in Semisolid Dosage Forms GMP Audit Template, EU Guidelines Dissolution Testing of Semisolid Dosage Forms Approved Excipients in Semisolid Dosage Forms Manufacturing Formulations Catalog no. H8126, September 2009, 376 pp. ISBN: 978-1-4200-8126-8, $199.95 / £127.00 Also available as an eBook
Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
While over-the-counter formulations have much in common with their prescription counterparts, they are presented in this series separately because of the development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products. Coverage in this volume includes medicinal products for human and veterinary use, World Health Organization good manufacturing guidelines, solid oral dosage forms validation, and the current regulatory status of over-the-counter products. Catalog no. H8128, September 2009, 480 pp. ISBN: 978-1-4200-8128-2, $199.95 / £127.00 Also available as an eBook
Handbook of Pharmaceutical Manufacturing Formulations Second Edition, Volume Six, Sterile Products Safaraz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
With the increasing number of potent products joining the long list of proven sterile products, the technology of manufacturing these products has evolved into a very sophisticated industry. Highlights of this volume include formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, NDA and aNDA filing requirements of sterile products, and formulations of pharmaceutical products based on their generic names. Catalog no. H8130, September 2009, 464 pp. ISBN: 978-1-4200-8130-5, $199.95 / £127.00 Also available as an eBook
Save on the Bestselling Set!
Handbook of Pharmaceutical Manufacturing Formulations Second Edition, Six-Volume Set Catalog no. H8106, September 2009, 2094 pp., ISBN: 978-1-4200-8106-0, $995.00 / £634.00 Also available as an eBook
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19
Pharmacology & Toxicology Coming Soon!
Coming Soon!
Leadership and Management in Pharmacy Practice
Kratom and Other Mitragynines
Second Edition
The Chemistry and Pharmacology of Opioids from a Non-Opium Source
Edited by
Andrew M. Peterson Mayes College of Healthcare Business & Policy, Philadelphia, Pennsylvania, USA
William N. Kelly William N. Kelly Consulting Inc., Oldsmar, Florida, USA
This book introduces students to leadership and management principles and practices commonly used in pharmacy practice. Examining the foundations of leadership and the management challenges leaders and practitioners face, it provides practical examples on how to solve some of the problems. This second edition takes a stronger approach to leadership, making it an integral part of every topic discussed throughout the text. The organization and design of Leadership and Management in Pharmacy Practice, Second Edition follows a learner-centered approach, using examples and focusing on problem solving and critical thinking.
Features: • Integrates external resources (websites, cases studies) for students to access while learning • Presents information to support student learning rather than as objects to memorize • Includes chapter summaries to highlight the most important information the student should know • Supplies group activities for instructors to use in classroom as primary learning tools An instructor's manual and figure slides are available upon qualifying course adoption
Contents: Leadership. The Principles and Characteristics of Leadership. Understanding and Working in the Organization and Its Mission. The Importance of Vision, Innovation, and Strategic Planning. Leading Culture, People, and the Strategic Plan. Leading Change and the Pharmacy Enterprise. Leading Yourself. Management. The Principles and Characteristics of Effective Pharmacy Management and Supervision. Managing Projects to Achieve Desired Results. Managing People. Managing Pharmacy Operations. Managing Clinical Services. Managing Advertising, Marketing, and the Budget. Managing Pharmacy Automation and Informatics. Managing Quality, Outcomes, and Compliance. Catalog no. K20416, December 2014, c. 352 pp. ISBN: 978-1-4665-8962-9, $99.95 / £63.99 Also available as an eBook
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Edited by
Robert B. Raffa Temple University School of Pharmacy, Philadelphia, Pennsylvania, USA
Morphine and other opioid drugs are extracts or analogs of compounds isolated from a single source, the opium poppy (Papaver somniferum). However, biological diversity has given rise to an alternative source. Specifically, at least two alkaloids isolated from the plant Mitragyna speciosa—and their synthetic analogs—display pain-relieving activity. Kratom and Other Mitragynines: The Chemistry and Pharmacology of Opioids from a Non-Opium Source presents an introduction to the chemical and biological properties of these agents and discusses the nature and extent of their use and abuse. The book covers the topic from phytochemistry, medicinal chemistry, and pharmacology perspectives and describes current research in computer modeling of the binding to the various opioid receptor sub-types.
Contents: Why Do Plants Contain Biologically Active Compounds? Short Overview of Mitragynines Psychopharmacological Indole Alkaloids from Terrestrial Plants Salvinorin A: Example of a Non-Alkaloidal Bioactive Opioid from a Plant Source Mitragyna speciosa (Korth.) Havil. Phytochemistry of Mitragyna speciosa Chemistry of Mitragynines: A Brief Introduction Chemistry of Mitragyna Compounds Medicinal Chemistry Based on Mitragynine Chemical Structures of Opioids The Detection of Mitragynine and Its Analogs The ADME of Mitragynine and Analogs Analgesic Effects of Mitragynine and Analogs Non-Analgesic CNS Effects Other Opioid-Associated Endpoints The Kratom Experience from Firsthand Reports The Toxicology of Indole Alkaloids Opioid-Induced Adverse Effects and Toxicity Toxicology of Mitragynine and Analogs The Use of Animal Models to Measure Tolerance, Dependence, and Abuse Potential Kratom: The Epidemiology, Use and Abuse, Addiction Potential, and Legal Status Catalog no. K22408, November 2014, c. 268 pp. ISBN: 978-1-4822-2518-1, $139.95 / £89.00 Also available as an eBook
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Pharmacology & Toxicology New!
Biointeractions of Nanomaterials
Basic Pharmacokinetics Second Edition
Edited by
Mohsen A. Hedaya
Vijaykumar B. Sutariya and Yashwant Pathak
Kuwait University, Safat
University of South Florida College of Pharmacy, Tampa, USA
The advent of nanotechnology and its applications in fields such as nano materials and nano systems have led to an increased concern about the safety and compatibility of these systems with biological systems. This is particularly true because the main routes of nano materials contact are inhalation, dermal absorption, and ingestion. Biointeractions of Nanomaterials addresses these issues related to toxicity and safety of nano materials and nano systems. It covers the range of interactions in biological systems and presents various tools and methods used for evaluation, including in vitro and in vivo techniques.
Contents: Introduction: Biointeractions of Nanomaterials: Challenges and Solutions; Nanoparticles Exposure in Occupational Environment; Physicochemical Characterization Dependent Toxicity of Nanoparticles Cytotoxicity of Stimuli-responsive Nanomaterials: Predicting Clinical Viability through Robust Biocompatibility Profiles Biosensing Devices for Toxicity Assessment of Nanomaterials Carbon Nanotubes and Pulmonary Toxicity Nanotoxicity of Polymeric and Solid Lipid Nanoparticles Analytical Characterization of Nanomaterials in Biological Matrices for Hazard Assessment Nanoparticles and Human Health: A Review of Epidemiological Studies Toxicogenomic Approach to Understand Toxicity of Nanoparticles Nanomaterial Based Gene and Drug Delivery: Pulmonary Toxicity Considerations Cardiovascular Toxicity of Nanomaterials Toxicity of Nanomaterials on Gastrointestinal Tract Toxicity of Nanomaterials on Liver, Kidney and Spleen; Jayvadan Patel, Anita Patel The Regulatory Implications of Nanotechnology; Lynn L. Bergeson, Michael F. Cole Ocular Toxicity of Nanoparticles; Anjali Hirani, Aditya Grover, YongWoo Lee, Vijaykumar Sutariya, Yashwant Pathak... Genotoxicity of Nanoparticles Catalog no. K18932, July 2014, 480 pp. ISBN: 978-1-4665-8238-5, $169.95 / ÂŁ108.00 Also available as an eBook
Knowledge of pharmacokinetics is critical to understanding the absorption, distribution, metabolism, and excretion of drugs. It is therefore vital to those engaged in the discovery, development, and preclinical and clinical evaluation of drugs, as well as practitioners involved in the clinical use of drugs. Using different approaches accessible to a wide variety of readers, Basic Pharmacokinetics: Second Edition demonstrates the quantitative pharmacokinetic relations and the interplay between pharmacokinetic parameters. Accompanying the book is a CD with self-instructional tutorials and pharmacokinetic and pharmacokinetic-pharmacodynamic simulations, allowing visualization of concepts for enhanced comprehension. This learning tool received an award from the American Association of Colleges of Pharmacy for innovation in teaching, making it a valuable supplement to this essential text.
Selected Contents: Review of Mathematical Fundamentals Drug Pharmacokinetics Following a Single IV Bolus Administration: Drug Distribution Drug Absorption Following Extravascular Administration: Biological, Physiological, and Pathological Considerations Drug Pharmacokinetics Following Single Oral Drug Administration: The Rate of Drug Absorption Bioequivalence Drug Pharmacokinetics during Constant Rate IV Infusion: The Steady-State Principle Steady State during Multiple Drug Administration Renal Drug Excretion Metabolite Pharmacokinetics Nonlinear Pharmacokinetics Multicompartment Pharmacokinetic Models Pharmacokinetic-Pharmacodynamic Modeling Noncompartmental Approach in Pharmacokinetic Data Analysis Physiological Approach to Hepatic Clearance Physiologically Based Pharmacokinetic Models Therapeutic Drug Monitoring Pharmacokinetics in Special Patient Populations Pharmacokinetic Drug-Drug Interactions Applications of Computers in Pharmacokinetics The Companion CD Solutions for the Practice Problems Catalog no. K12311, February 2012, 595 pp. ISBN: 978-1-4398-5073-2, $93.95 / ÂŁ59.99 Also available as an eBook
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Pharmacology & Toxicology Pharmacy What It Is and How It Works, Third Edition William N. Kelly William N. Kelly Consulting Inc., Oldsmar, Florida, USA
Now in its third edition, this volume continues to provide a comprehensive review of all aspects of pharmacy, from the various roles of pharmacists to particular health care-related events to career planning information. The book discusses distribution, prescribing, dispensing, and pricing and an expanded chapter on informatics explores how pharmacy has evolved through information technology and automation. Additional chapters cover poison control, pharmacy schools, pharmacy organizations, the drug approval process, and career development. The book contains numerous tools to facilitate comprehension, including learning objectives, discussion questions and exercises to test assimilation, and websites and references to encourage further study. Catalog no. K12446, July 2011, 488 pp. ISBN: 978-1-4398-5305-4, $65.95 / £42.99 Also available as an eBook
Textbook of Receptor Pharmacology Third Edition Edited by
John C. Foreman and Alasdair J. Gibb University College London, UK
Torben Johansen University of Southern Denmark, Odense
Originating from a renowned course on receptor pharmacology, this text presents in-depth coverage of this rapidly expanding research area. The book combines current understanding of classical quantitative pharmacology and drug-receptor interactions with the basics of receptor structure and signal transduction mechanisms. It focuses on molecular investigation of receptor structure, quantitative functional studies of agonists and antagonists, ligand binding, and signal transduction at the cell membrane. This edition includes updated chapters on receptor structure and signal transduction by G-proteins and tyrosine kinases as well as enhancements to the quantitative treatment of drug-receptor interactions. Several chapters contain problems and worked-out solutions. Catalog no. 52543, September 2010, 303 pp. ISBN: 978-1-4200-5254-1, $125.95 / £82.00 Also available as an eBook
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Essentials of Law and Ethics for Pharmacy Technicians Third Edition Kenneth M. Strandberg North Dakota State University, Fargo, USA
Addressing the latest procedural, ethical, and technological developments in this rapidly changing field, this third edition of the bestselling Essentials of Law and Ethics for Pharmacy Technicians includes an appendix on the legal standing of electronic transmission of prescriptions. It covers U.S. state and federal regulations pertaining to the administration of new medications, including birth control and the morning-after pill, as well as current regulations on over-the-counter label claims. An essential resource for students as well as practicing technicians, this reference brings together the information that pharmacy technicians need to practice in a manner that is both legal and ethical.
Selected Contents: The Legal System in the United States Legislation, Regulation, and Interpretation Criminal versus Civil Law History and Development of Current Law Into the Twentieth Century Food, Drug, and Cosmetic Act Of 1938 Adulteration Misbranding Drug Samples Investigational New Drugs New Drug Applications The Drug Price Competition and Patent-Term Restoration Act of 1984 The Orphan Drug Act of 1983 Prescribing Requirements and Restrictions Dispensing Requirements and Restrictions Drug Pedigrees Federal Controlled Substance Act of 1970 Other Pertinent Federal Legislation Ethics Theory and Application The Development of Pharmaceutical Ethical Considerations Code of Ethics Background And Progression Pharmacy — A Respected Tradition Pharmacy-Related Relationships Communicating Professionally in an Information Age Patient’s Rights Modern Controversial Issues Catalog no. K12451, July 2011, 186 pp. ISBN: 978-1-4398-5315-3, $58.95 / £37.99 Also available as an eBook
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NEW!
Biointeractions of Nanomaterials Edited by
Vijaykumar B. Sutariya and Yashwant Pathak University of South Florida College of Pharmacy, Tampa, USA
Explore the Range of Interactions in Biological Systems An examination of the widespread application of nanomaterials in biology, medicine, and pharmaceuticals and the accompanying safety concerns, Biointeractions of Nanomaterials addresses the issues related to toxicity and safety of nanomaterials and nano systems.
• Addresses the assessment and characterization of nano systems in bio-environments • Presents various tools and methods used to evaluate toxicity and safety issues • Explores bio-sensing devices for toxicity assessment
• Discusses carbon nano tubes and pulmonary toxicity • Examines nano toxicity of solid lipid nanoparticles • Profiles the effects of nano particles on different organs • Describes the regulatory implications of nanomaterials
Catalog no. K18932, July 2014, 480 pp., ISBN: 978-1-4665-8238-5, $169.95 / £108.00 Also available as an eBook
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