Applications of Model Informed Drug Development (MIDD) in Drug Development Lifecycle and Regulatory Review

被引：7
作者：
Mitra, Amitava [1 ,2 ]
Wang, Yaning [3 ]
机构：
[1] Janssen R&D, Clin Pharmacol & Pharmacometr, Spring House, PA 19477 USA
[2] Kura Oncol, Clin Pharmacol, San Diego, CA 92130 USA
[3] Createrna Sci & Technol, Wuhan, Peoples R China
来源：
PHARMACEUTICAL RESEARCH | 2022年 / 39卷 / 08期
关键词：
D O I：
10.1007/s11095-022-03327-6
中图分类号：
O6 [化学];
学科分类号：
0703 ;
摘要：
[No abstract available]
引用
收藏
页码：1663 / 1667
页数：5
相关论文
共 34 条
[1]   The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives [J].
Anand, Om ;
Pepin, Xavier J. H. ;
Kolhatkar, Vidula ;
Seo, Paul .
PHARMACEUTICAL RESEARCH, 2022, 39 (08) :1681-1700
[2]  
[Anonymous], 2018, FDA ISOP PUBLIC WORK
[3]  
[Anonymous], PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017
[4]  
[Anonymous], 2022, PHARM RES-DORDR
[5]  
[Anonymous], FED REG BEST PRACTIC
[6]  
[Anonymous], US FDA MODEL INFORM
[7]  
[Anonymous], OUTPUT ICH MODEL INF
[8]  
[Anonymous], EMA GUIDELINES REPOR
[9]   Model Informed Drug Development: Collaboration Through A Common Framework [J].
Anziano, Richard J. ;
Milligan, Peter A. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2021, 110 (05) :1165-1167
[10]   Role of Disease Progression Models in Drug Development [J].
Barrett, Jeffrey S. ;
Nicholas, Tim ;
Azer, Karim ;
Corrigan, Brian W. .
PHARMACEUTICAL RESEARCH, 2022, 39 (08) :1803-1815
1234