A Question-Based Approach to Adopting Pharmacogenetics to Understand Risk for Clinical Variability in Pharmacokinetics in Early Drug Development

被引：4

作者：

Evers, R. ^{[1
]}

Blanchard, R. L. ^{[2
]}

Warner, A. W. ^{[2
]}

Cutler, D. ^{[3
]}

Agrawal, N. G. B. ^{[4
]}

Shaw, P. M. ^{[5
]}

机构：

[1] Merck & Co Inc, Dept Pharmacokinet Pharmacodynam & Drug Metab, Rahway, NJ USA

[2] Merck & Co Inc, Clin Pharmacogenom, N Wales, PA USA

[3] Merck & Co Inc, Clin Pharmacol, N Wales, PA USA

[4] Merck & Co Inc, Dept Pharmacokinet Pharmacodynam & Drug Me, West Point, PA USA

[5] Merck & Co Inc, Clin Pharmacogenom, West Point, PA 19486 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2014年 / 96卷 / 03期

关键词：

D O I：

10.1038/clpt.2014.98

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Understanding genetic variations that influence pharmacokinetics (PK) in humans is important for optimal clinical use of drugs. Guidances for making decisions on when to conduct pharmacogenetic research during drug development have been proposed by regulatory agencies, but their uniform adoption presents problems due to an inherent lack of flexibility. A questions-based approach (QBA) was developed to enable drug development teams at Merck to iteratively and flexibly evaluate the potential impact of pharmacogenetics (PGx) on clinical pharmacokinetic variability.

引用

页码：291 / 295

页数：5

共 5 条

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