Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

• Main Authors: Fang Wu (Author), Youssef Mousa (Author), Kimberly Raines (Author), Chris Bode (Author), Yu Chung Tsang (Author), Rodrigo Cristofoletti (Author), Hongling Zhang (Author), Tycho Heimbach (Author), Lanyan Fang (Author), Filippos Kesisoglou (Author), Amitava Mitra (Author), James Polli (Author), Myong‐Jin Kim (Author), Jianghong Fan (Author), Banu S. Zolnik (Author), Duxin Sun (Author), Yi Zhang (Author), Liang Zhao (Author)
• Format: Book
• Published: Wiley, 2023-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches," a jointly sponsored workshop by the US Food and Drug Administration (FDA) and the...