Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions.

导出 LinkOut

翻译打印收藏纠错

作者： Vishnu Dutt,Sharma ^[1] ; Venkatesh Atul,Bhattaram ^[1] ; Kevin,Krudys ^[2] ; Zhihua,Li ^[1] ; Anshu,Marathe ^[1] ; Nitin,Mehrotra ^[1] ; Xiaofeng,Wang ^[1] ; Jiang,Liu ^[1] ; Ethan,Stier ^[1] ; Jeffry,Florian ^[1] ; Raj,Madabushi ^[1] ; Hao,Zhu ^[1]

作者单位： Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. ^[1] Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. ^[2]

关键词 505(b)(2) applications evidence of effectiveness informing dosing in subgroups informing policy model‐informed drug development

主题词人类(Humans);美国食品和药物管理局(United States Food and Drug Administration);药物批准(Drug Approval);美国(United States);模型, 生物学(Models, Biological);决策(Decision Making)

DOI 10.1002/jcph.6109

PMID 39120874

发布时间 2024-12-03

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交