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

Start
Tuesday, April 26, 2022
9:00 AM
End
Thursday, April 28, 2022
12:00 PM

Registration

Members – $75.00
Non-members – $125.00
Includes one year of SAAMnow membership

Registration is closed

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.