Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Absorption Systems, Exton, Pennsylvania, USA.
Clin Pharmacol Ther. 2021 Nov;110(5):1190-1195. doi: 10.1002/cpt.2120. Epub 2020 Dec 29.
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.
2020 年 5 月 4 日，美国食品和药物管理局（FDA）举办了一次名为“2020 年仿制药监管科学倡议公开研讨会”的网络公开研讨会，旨在概述科学和研究重点的现状，并就仿制药用户收费修正案 2021 年优先事项的制定征求意见。本报告总结了专题介绍和讨论的结果，以及在突破会议 4 中提出的用于克服基于模型的生物等效性评估方法的挑战和重要机遇的创新方法，会议 4 的标题为“数据分析和基于模型的生物等效性（BE）”。本次会议的重点是在仿制药开发中应用基于模型的方法，旨在加速简化新药申请评估的监管决策。会议包括专题介绍和小组讨论，涵盖了三个感兴趣的主题：（i）体外研究评估方法及其临床相关性，（ii）基于模型的 BE 中的挑战，（iii）实施新 BE 方法的新兴专业知识和工具。
