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Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop. 2023
Yuqing Gong, and
Peijue Zhang, and
Miyoung Yoon, and
Hao Zhu, and
Ameya Kohojkar, and
Andrew C Hooker, and
Murray P Ducharme, and
Jogarao Gobburu, and
Géraldine Cellière, and
Parmesh Gajjar, and
Bing V Li, and
Raja Velagapudi, and
Yu Chung Tsang, and
Anna Schwendeman, and
James Polli, and
Lanyan Fang, and
Robert Lionberger, and
Liang Zhao
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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 Implantable (LAI) Drug Products." This workshop brought relevant parties from the industry, academia, and the FDA in the field of modeling and simulation to explore, identify, and recommend best practices on utilizing MIE for bioequivalence (BE) assessment of LAI products. This report summerized presentations and panel discussions for topics including challenges and opportunities in development and assessment of generic LAI products, current status of utilizing MIE, recent research progress of utilizing MIE in generic LAI products, alternative designs for BE studies of LAI products, and model validation/verification strategies associated with different types of MIE approaches.
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