Filing an IND and Beyond: Development of CTD Section 2.6.4, Pharmacokinetics Written Summary
Learn about what CTD Section 2.6.4 consists of, the studies that are expected and how you develop the section over time from discovery to registering the compound. Key topics include:
- Generation of ADME data for an NCE throughout development
- Contents of final filing package
- What ADME data should be contained at the time of IND
- Types of ADME data typically found in IND
- Interdependencies with other non-clinical sections
- Additional detail on human dose projection and DILI liability prediction
This presentation was one of the keynote presentations from XenoTech's XenoTalks™ Seminar Series on the importance of ADME and Drug-Drug Interactions in drug development. You can register for or request a seminar here: https://www.xenotech.com/about/events/2022-seminar-series-the-importance-of-adme-and-ddi-in-drug-development/ or register to receive notifications of future events here: https://www.xenotech.com/contact/newsletter-sign-up/. These fully interactive events provide in-depth presentations from industry experts along with free food and drinks and good conversations. They cover various topics around pharmaceutical non/preclinical testing with specifics on how to effectively move compounds through the development pipeline.
About the presenter:
Griff Humphreys, Ph.D., is on XenoTech's team of external consultants. Prior to consulting, he spent 26 years at Bristol-Myers Squibb Pharmaceutical Company, with the last 12 years leading the Biotransformation Department. He received his graduate training at the University of Virginia in chemistry and completed a postdoctoral fellowship at Vanderbilt University in the Center in Molecular Toxicology. His research interests include the consequences of reactive metabolite formation, development of new analytical methodologies for metabolite detection, reaction phenotyping of CYP- and UGT-catalyzed biotransformations, predictive metabolism and toxicology models, in vitro–in vivo correlations, and strategies for candidate optimization. He has co-authored over 120 refereed manuscripts and numerous reviews and book chapters. Dr. Humphreys is a member of the ISSX and the ACS Chemical Toxicology Division (TOXI). He is on the Editorial Advisory Boards of Drug Metabolism and Disposition and serves as reviewer for multiple additional journals. He has served on the Executive Committee of TOXI since 2008 and most recently as Program Chair for the 2013-2014 National meetings. He is currently a member of the ISSX Council and was a member of the Meeting Organizing Committee for the 22nd NA ISSX Meeting.
