This virtual workshop was held April 26-28, 2022 and covered the following topics:
Session 1: 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: 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: 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