Scientific perspectives on drug transporters and their role in drug interactions

被引:125
作者
Zhang, Lei [1 ]
Strong, John M. [1 ]
Qiu, Wei [1 ]
Lesko, Lawrence J. [1 ]
Huang, Shiew-Mei [1 ]
机构
[1] CIDER Off 1, Ctr Drug Evaluat & Res Food & Drug Adm, Off Clin Pharmacol & Biopharmaceut, Silver Spring, MD 20993 USA
关键词
transporter; drug-drug interaction; regulatory; guidance; new drug application; drug development; exposure-response relationship; labeling; risk management;
D O I
10.1021/mp050095h
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Recently, increased interest in drug transporters and research in this area has revealed that drug transporters play an important role in modulating drug absorption, distribution, and elimination. Acting alone or in concert with drug metabolizing enzymes they can affect the pharmacokinetics and pharmacodynamics of a drug. This commentary will focus on the potential role that drug transporters may play in drug-drug interactions and what information may be needed during drug development and new drug application (NDA) submissions to address potential drug interactions mediated by transporters.
引用
收藏
页码:62 / 69
页数:8
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