基于模型的仿制药研发与审评：FDA 公开专题研讨会总结
Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.
机构信息
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
出版信息
Clin Pharmacol Ther. 2018 Jul;104(1):27-30. doi: 10.1002/cpt.1065. Epub 2018 Mar 30.
On October 2 and 3 , 2017, the US Food and Drug Administration (FDA) hosted a public workshop titled "Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review." This report summarizes Session 2 of the public workshop: "Model Informed Drug Development and Review for Generic Products." The session focused on the application of quantitative methods and modeling in modernizing the generic drug development and review.
2017 年 10 月 2 日和 3 日，美国食品和药物管理局（FDA）举办了一场题为“利用定量方法和建模使仿制药开发和审评现代化”的公开研讨会。本报告总结了公开研讨会的第 2 场会议：“用于仿制药的基于模型的药物开发和审评”。本次会议的重点是在使仿制药开发和审评现代化方面应用定量方法和建模。
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