A regulatory perspective on pharmacokinetic/pharmacodynamic modelling

被引：20

作者：

Machado, SG

Miller, R

Hu, C

机构：

[1] US FDA, Off Biostat, CDER, HFD 705, Rockville, MD 20857 USA

[2] US FDA, Off Clin Pharmacol & Biopharmaceut, Rockville, MD 20857 USA

来源：

STATISTICAL METHODS IN MEDICAL RESEARCH | 1999年 / 8卷 / 03期

关键词：

D O I：

10.1191/096228099674515377

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

We present an integrated summary from statistical and pharmacological perspectives of pharmacokinetic/pharmacodynamic (PK/PD) modelling and its use in drug development and regulation for guiding appropriate dosing. An overview of the technical aspects of PK/PD modelling describes how structural models are constructed and refined using pharmacokinetic and pharmacodynamic principles and how random effects models are used to account for individual differences in desired (and undesired) responses due to patient characteristics. Lastly, we describe applications of PK/PD modelling for the purposes of drug labelling, for resolving a safety concern, and for improving therapeutic monitoring of anaesthetic depth during surgery.

引用

页码：217 / 245

页数：29

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