Confidence in Generic Drug Substitution

被引：11

作者：

Lionberger, R. ^{[1
]}

Jiang, W. ^{[1
]}

Huang, S-M ^{[2
]}

Geba, G. ^{[1
]}

机构：

[1] US FDA, Off Gener Drugs, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA

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

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2013年 / 94卷 / 04期

关键词：

D O I：

10.1038/clpt.2013.104

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Patients should have confidence that the generic drugs they are prescribed in the United States can be effectively substituted for the brand product or another generic product. Through new bioequivalence study designs for narrow therapeutic index (NTI) drugs and postapproval studies of generic substitution, the US Food and Drug Administration's (FDA's) ongoing generic drug regulatory science activities are designed to ensure successful generic substitution for all drug products.

引用

页码：438 / 440

页数：4

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