Regulatory Utility of Physiologically Based Pharmacokinetic Modeling for Assessing Food Impact in Bioequivalence Studies: A Workshop Summary Report.

This workshop report summarizes the presentations and panel discussion related to the utilization of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from session-2 of day-2 of the workshop titled "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches". The U.S. Food and Drug Administration (FDA) in collaboration with the Center for Research on Complex Generics (CRCG) organized this workshop where this particular session titled, "Oral PBPK for Evaluating the Impact of Food on BE" was designed to present successful cases of PBPK modeling approaches for food effect assessment. Recently, PBPK modeling has started to gain popularity among academia, industries and regulatory agencies for its potential utility during bioavailability (BA) and/or bioequivalence (BE) studies of new and generic drug products to assess the impact of food on BA/BE. Considering the promises of PBPK modeling in generic drug development, the aim of this workshop session was to facilitate knowledge sharing among academia, industries and regulatory agency to understand the knowledge gap and guide the path forward. This report collects and summarizes the information presented and discussed during this session in order to disseminate the information into a broader audience for further advancement in this area.