STEREOISOMERIC DRUGS - FDAS POLICY STATEMENT AND THE IMPACT ON DRUG DEVELOPMENT

被引：41

作者：

TOMASZEWSKI, J ^{[1
]}

RUMORE, MM ^{[1
]}

机构：

[1] ARNOLD & MARIE SCHWARTZ COLL PHARM,BROOKLYN,NY

来源：

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY | 1994年 / 20卷 / 02期

关键词：

D O I：

10.3109/03639049409039080

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

On May 1, 1992 FDA issued its long awaited policy statement concerning the development of stereoisomeric drugs. These drugs are also known as ''chiral drugs.'' This paper will focus on the historical perspective of the stereoisomer issue, review of FDA's policy and a discussion of the potential impact of this policy on drug development including the impact on marketing exclusivity.

引用

页码：119 / 139

页数：21

共 50 条

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不详
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不详
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