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

• मुख्य लेखकों: Andrew Babiskin (लेखक), Fang Wu (लेखक), Youssef Mousa (लेखक), Ming‐Liang Tan (लेखक), Eleftheria Tsakalozou (लेखक), Ross L. Walenga (लेखक), Miyoung Yoon (लेखक), Sam G. Raney (लेखक), James E. Polli (लेखक), Anna Schwendeman (लेखक), Vishalakshi Krishnan (लेखक), Lanyan Fang (लेखक), Liang Zhao (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: Wiley, 2023-05-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: 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...