Teratogenic Drugs and Their Drug Interactions With Hormonal Contraceptives

被引：6

作者：

Ahn, M. R. ^{[1
]}

Li, L. ^{[1
]}

Shon, J. ^{[1
]}

Bashaw, E. D. ^{[1
]}

Kim, M-J ^{[1
]}

机构：

[1] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2016年 / 100卷 / 03期

关键词：

D O I：

10.1002/cpt.384

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The US Food and Drug Administration (FDA) Guidance for IndustryDrug Interaction Studies, recommends that a potential human teratogen needs to be studied in vivo for effects on contraceptive steroids.(1) This article highlights the need to evaluate the drug-drug interactions (DDIs) between drugs with teratogenic potential and hormonal contraceptives (HCs) during drug development. It also addresses the FDA's effort of communicating DDI findings in product labels to mitigate the risk of unintended pregnancy.

引用

页码：217 / 219

页数：3

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