Senior Pharmacologist U.S. Food & Drug Administration Silver Spring, Maryland
This talk will introduce the regulatory research results on using Physiologically-Based Pharmacokinetic (PBPK) modeling to project the impact of food on drug absorption. The goal of this presentation is to introduce the experiences, challenges and share views with the participants on how to apply in vitro and in silico approaches to evaluate the risk of food impact on bioequivalence (BE) and support decision making during drug development and regulatory assessment. This presentation will also introduce how to implement these approaches in assessing the impact of food on the bioequivalence of generic drugs.
Learning Objectives:
learn the scientific advances in the use of Physiologically-Based Pharmacokinetic (PBPK) modeling approaches to quantitively predict the impact of food on relative bioavailability and bioequivalence
know challenges of implementing these approaches in assessing the impact of food on the relative bioavailability and bioequivalence for investigational drugs
leverage knowledge learned in the rapid fire to help understand and conduct risk asessment of food impact on relative bioavailability and bioequivalence
