Prologue: PBPK/PBBM to Inform the Bioequivalence Safe Space, Food Effects, and pH-Mediated DDIs

Tuesday, October 18, 2022

8:30 AM – 9:00 AM ET

Location:151 AB

Prologue Speaker(s)

Tycho Heimbach, PhD

Senior Principal Scientist/Director
Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA, New Jersey

Handouts

Part 1: PBBM (Physiologically Based Biopharmaceutics Modeling) in Drug
Development
- PBBM Overview, PBBM Draft Guidance, Terminology
- General Applications
- Bioequivalence Safe Space
- Case Study

Part 2: PBBM to anticipate Food Effects and pH-mediated DDI risks in specific populations
and to inform formulation development
- ARA Overview, ARA Draft Guidance
- Predictable Food Effect Studies
- Case Studies

Learning Objectives:

Learn about recent applications of PBBM to define Bioequivalence Safe Space
Be familiar with PBBM application for drug product quality e.g. to set CRDS (clinically relevant disso. specifications)
Be familiar with the use of PBPK for repeat food effect studies
Be familiar with the use of PBPK to anticipate/remediate pH-mediated DDI with ARA’s
Learn about the use of dissolution models to identify BA/BE of bridging studies, e.g. capsule to tablet formulations for clin pharm studies