Abstract

On May 4, 2020, the US Food and Drug Administration (FDA) hosted an online public workshop titled “FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop” to provide an overview of the status of the science and research priorities and to solicit input on the development of Generic Drug User Fee Amendments fiscal year 2021 priorities. This report summarizes the podium presentations and the outcome of discussions along with innovative ways to overcome challenges and significant opportunities related to model‐based approaches in bioequivalence assessment for breakout session 4 titled, “Data analysis and model‐based bioequivalence (BE).” This session focused on the application of model‐based approaches in the generic drug development, with a vision of accelerating regulatory decision making for abbreviated new drug application assessments. The session included both podium presentations and panel discussions with three topics of interest: (i) in vitro study evaluation methods and their clinical relevance, (ii) challenges in model‐based BE, (iii) emerging expertise and tools in implementing new BE approaches.

By Jieon Lee Yuqing Gong Sid Bhoopathy Charles E. DiLiberti Andrew C. Hooker Amin Rostami‐Hodjegan Stephan Schmidt Sandra Suarez‐Sharp Viera Lukacova Lanyan Fang Liang Zhao