Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Division of Biostatistics, Center for Biologics Evaluation and Research, Office of Biostatistics and Pharmacovigilance, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Ther Innov Regul Sci. 2023 May;57(3):436-444. doi: 10.1007/s43441-022-00483-0. Epub 2022 Dec 2.
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) have been leaders in protecting and promoting the U.S. public health by helping to ensure that safe and effective drugs and biological products are available in the United States for those who need them. The null hypothesis significance testing approach, along with other considerations, is typically used to demonstrate the effectiveness of a drug or biological product. The Bayesian framework presents an alternative approach to demonstrate the effectiveness of a treatment. This article discusses the Bayesian framework for drug and biological product development, highlights key settings in which Bayesian approaches may be appropriate, and provides recent examples of the use of Bayesian approaches within CDER and CBER.
美国食品药品监督管理局（FDA）的药品评价和研究中心（CDER）和生物制品评价和研究中心（CBER）一直致力于保护和促进美国公众健康，帮助确保安全有效的药物和生物制品在美国供应给有需要的人。零假设显著性检验方法，以及其他考虑因素，通常用于证明药物或生物制品的有效性。贝叶斯框架提供了一种替代方法来证明治疗的有效性。本文讨论了药物和生物制品开发的贝叶斯框架，强调了贝叶斯方法可能适用的关键设置，并提供了 CDER 和 CBER 内使用贝叶斯方法的最新示例。
