Pharmacokinetic Aspects of the Development of Protein-based Therapeutics This webinar will help attendees understand what is needed from a Pharmacokinetic (PK) perspective to successfully navigate the development process of protein-based therapeutics. It will discuss FDA and EMEA guidelines for the development of protein therapeutics Why Should You Attend: Biotechnology companies are consistently under pressure to develop potential new drugs under very tight budgets and timelines. One of the things that can get lost in the process is conducting well thought-out Pharmacokinetic (PK) studies geared to address the specific questions that come with the development of protein therapeutics. Unfortunately, not obtaining the proper PK data at each stage of the development process can lead to poorly planned studies and toxicological or pharmacological data that are difficult to interpret, which in turn can lead to project delays and increased program costs. However, by understanding the importance of PK data and what data is needed when, these pitfalls can be avoided. This Pharmacokinetic webinar will:
Focus on early preclinical research through Phase 1 clinical PK. Discuss differences between protein therapeutics and chemical-based drugs with regards to their PK characterization. Explain appropriate types of studies (and PK objectives) that should be considered at various stages of development. Review how PK data from each stage of development feeds into the subsequent stages, including how preclinical data is used to plan for clinical studies. Discuss assay support and the effect of anti-drug antibodies on protein PK.
Areas Covered in the Webinar:
PK differences between proteins and chemical-based drugs FDA and EMEA guidelines for the development of protein therapeutics Preclinical PK data needed in support of a protein therapeutic INDs o Appropriate study endpoints o Study design considerations Assay support Effects of anti-drug antibodies (ADAs) How PK data from each stage of development supports planning for subsequent stages Scaling of preclinical PK to clinical o Calculating exposure-based safety margins First-in-human PK considerations
Who Will Benefit: This webinar will provide valuable information to:
Drug development scientists who are new to the field of protein-based therapeutics Non-PK scientists, such as toxicologists and clinical researchers, who are interested in learning more about the PK components of drug development PK scientists who are new to industry or drug development in general Project managers who would like to improve their understanding of this portion of the drug development process
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