(VIRTUAL WORKSHOP) Challenges and Strategies for Relative Bioavailability Studies on Drug Products Involving Endogenous Substances

SAAMnow Workshop: Challenges and Strategies for Relative Bioavailability Studies on Drug Products Involving Endogenous Substances

Session 1 (Tuesday April 26, 2022 9:00 AM – 12:00 PM EDT): Design and Conduct of Relative Bioavailability Studies on Drug Products Involving Endogenous Substances Moderator Times

• Topic 1: Design and conduct of pharmacokinetic bioequivalence studies on drug products involving endogenous substances: clinical considerations
• Topic 2: Challenges in pharmacokinetic assessment of endogenous substances administered exogenously
• Panel Discussion

Session 2 (Wednesday, April 27, 2022 9:00 AM – 12:00 PM EDT): Data Analysis and Statistical Challenges

• Topic 1: Baseline measurements and correction issues
• Topic 2: PK and statistical issues
• Topic 3: FDA perspectives on data analysis issues

Session 3 (Thursday, April 28, 2022 9:00 AM – 12:00 PM EDT): Bioanalysis of Endogenous Analytes: Overview, Method Validation Considerations, and Case Studies

• Topic 1: An overview of bioanalysis of endogenous analytes
• Topic 2: Validation of methods for endogenous analytes
• Topic 3: Challenges in the quantitative analysis of endogenous analytes: case studies

Click here for agenda.