Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

• Main Authors: Yuqing Gong (Author), Peijue Zhang (Author), Miyoung Yoon (Author), Hao Zhu (Author), Ameya Kohojkar (Author), Andrew C. Hooker (Author), Murray P. Ducharme (Author), Jogarao Gobburu (Author), Géraldine Cellière (Author), Parmesh Gajjar (Author), Bing V. Li (Author), Raja Velagapudi (Author), Yu Chung Tsang (Author), Anna Schwendeman (Author), James Polli (Author), Lanyan Fang (Author), Robert Lionberger (Author), Liang Zhao (Author)
• Format: Book
• Published: Wiley, 2023-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled "Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence for Long‐Acting Injectable and I...