Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

• Main Authors: Andrew Babiskin (Author), Fang Wu (Author), Youssef Mousa (Author), Ming‐Liang Tan (Author), Eleftheria Tsakalozou (Author), Ross L. Walenga (Author), Miyoung Yoon (Author), Sam G. Raney (Author), James E. Polli (Author), Anna Schwendeman (Author), Vishalakshi Krishnan (Author), Lanyan Fang (Author), Liang Zhao (Author)
• Format: Book
• Published: Wiley, 2023-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches." The overall aims...