When to Conduct a Renal Impairment Study During Drug Development: US Food and Drug Administration Perspective

被引：75

作者：

Huang, S-M ^{[1
]}

Temple, R. ^{[2
]}

Xiao, S. ^{[3
]}

Zhang, L. ^{[1
]}

Lesko, L. J. ^{[1
]}

机构：

[1] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Off Med Policy, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[3] US FDA, Div Cardiorenal Drug Prod, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2009年 / 86卷 / 05期

关键词：

GLOMERULAR-FILTRATION-RATE; IMPACT;

D O I：

10.1038/clpt.2009.190

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

To optimize drug therapy for individuals, it is critical to understand how various intrinsic (e.g., age, gender, race, genetics, organ impairment) and extrinsic factors (e.g., diet, smoking, concomitantly administered drugs) affect drug exposure and response.(1) Up to now, it has been far easier to discover effects on exposure caused by these factors, and the US Food and Drug Administration (FDA) has published several guidance documents with recommendations on how to evaluate these factors during drug development.

引用

页码：475 / 479

页数：6

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