This report summarizes the proceedings of Session 1 of the one-day public workshop titled “ Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development ” hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023. This report focuses on cutting-edge developments, ongoing challenges, and potential solutions in the field of physiolog...

This report summarizes the proceedings for Session 3 of the one-day public workshop entitled “Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development” a jointly sponsored workshop by U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023. The theme of this session was the application and relevant considerations for PBPK modeling in suppo...

While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on VBE outcomes requires demonstration of its ability not only in predicting formulation-dependent systemic exposure but also the expected degree of population variability. The concept of variation influencing the outcome...