Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the US Food and Drug Administration's Office of Clinical Pharmacology
Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the US Food and Drug Administration's Office of Clinical Pharmacology
复制标题
DOI：
10.1016/j.xphs.2018.10.033
复制
发表时间：
2019-01-01
影响因子：
3.8
通讯作者：
Wang, Yaning
中科院分区：
文献类型：
--
作者：
Grimstein, Manuela;Yang, Yuching;Wang, Yaning
这篇评论提供了美国食品和药物管理局临床药理学办公室基于生理的药代动力学建模和模拟的最新状况。强调了整合基于生理学的药代动力学方法为监管决策提供信息的局限性和知识差距，以及与打算使用这种方法的药物开发人员进行科学参与的重要性。(c) 2019年美国药剂师协会(R)。Elsevier Inc.出版。版权所有。
This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Limitations and knowledge gaps in integration of physiologically based pharmacokinetic approach to inform regulatory decision making, as well as the importance of scientific engagement with drug developers who intend to use this approach, are highlighted. (c) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.