Therapeutic Protein-Drug Interactions and Implications for Drug Development

被引：101

作者：

Huang, S-M ^{[1
]}

Zhao, H. ^{[1
]}

Lee, J-I ^{[1
]}

Reynolds, K. ^{[1
]}

Zhang, L. ^{[1
]}

Temple, R.

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

机构：

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

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2010年 / 87卷 / 04期

关键词：

MONOCLONAL-ANTIBODIES; METABOLIZING-ENZYMES; TRANSPORTERS; PHARMACOKINETICS; COMBINATION; INFLAMMATION; PERSPECTIVE; CETUXIMAB; DISEASE; IMPACT;

D O I：

10.1038/clpt.2009.308

中图分类号：

R9 [药学];

学科分类号：

100702 [药剂学];

摘要：

Many intrinsic and extrinsic factors can affect an individual patient's drug exposure and response.(1) The US Food and Drug Administration (FDA) has published a number of guidances that recommend how and when to evaluate these factors during drug development.(2) The most recent FDA draft guidance on drug interactions(3) provides advice for in vitro and in vivo drug interaction studies, including suggestions for study design, dosing strategies and analysis, and interpretation of data for medical product labels. The draft guidance(3) updated the FDA's recommendations on the evaluation of important cytochrome P450 (CYP) enzyme- and transporter-based drug interactions during drug development.

引用

页码：497 / 503

页数：7

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