Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making

被引:46
作者
Gobburu, JVS
Marroum, PJ
机构
[1] US FDA, Off Clin Pharmacol & Biopharmaceut, Ctr Drug Evaluat & Res, Div Pharmacometr, Rockville, MD 20852 USA
[2] US FDA, Div Pharmaceut Evaluat 1, Off Clin Pharmacol & Biopharmaceut, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
关键词
D O I
10.2165/00003088-200140120-00001
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Modelling and simulation (M&S) play an important role in regulatory decision making that affects both the public and industry. Technological advances in various fields related to drug development call for more focus on ways to optimise current drug development practices. Recognition of the potential of M&S by regulatory agencies inevitably has a substantial impact on drug development. The objective of the current review is to present the various regulatory initiatives for application of M&S to clinical drug development. The relevant parts of the various recommendations issued by the US Food and Drug Administration (FDA), Via guidance documents and advisory committee meeting proceedings, are highlighted. Application of M&S to a variety of activities, such as integrating pharmacokinetic-pharmacodynamic knowledge across a new drug application and designing efficient trials, is discussed. Some of the challenges that Pharmaceutical institutions currently face when implementing M&S projects, such as team structure, communication with regulators, training and time constraints, are also presented, and solutions are proposed.
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页码:883 / 892
页数:10
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