In Vitro and in Vivo Induction of Cytochrome P450: A Survey of the Current Practices and Recommendations: A Pharmaceutical Research and Manufacturers of America Perspective

被引：113

作者：

Chu, Valeria ^{[2
]}

Einolf, Heidi J. ^{[3
]}

Evers, Raymond ^{[5
]}

Kumar, Gondi ^{[1
]}

Moore, David ^{[6
]}

Ripp, Sharon ^{[7
]}

Silva, Jose ^{[8
]}

Sinha, Vikram ^{[9
]}

Sinz, Michael ^{[10
]}

Skerjanec, Andrej ^{[4
]}

机构：

[1] Celgene Corp, Summit, NJ 07901 USA

[2] Sanofi Aventis US, Bridgewater, NJ USA

[3] Novartis Pharmaceut, E Hanover, NJ USA

[4] Novartis Pharmaceut, Florham Pk, NJ USA

[5] Merck & Co Inc, Rahway, NJ 07065 USA

[6] Roche, Nutley, NJ USA

[7] Pfizer Global Res & Dev, Groton, CT USA

[8] Johnson & Johnson, Raritan, NJ USA

[9] Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA

[10] Bristol Myers Squibb Co, Wallingford, CT 06492 USA

来源：

DRUG METABOLISM AND DISPOSITION | 2009年 / 37卷 / 07期

关键词：

PREGNANE-X-RECEPTOR; CONSTITUTIVE ANDROSTANE RECEPTOR; DRUG-METABOLIZING-ENZYMES; ERYTHROMYCIN BREATH TEST; ARYL-HYDROCARBON RECEPTOR; PRIMARY HUMAN HEPATOCYTES; HEPATOMA-CELL LINE; HUMAN LIVER SLICES; NUCLEAR RECEPTORS; XENOBIOTIC RECEPTOR;

D O I：

10.1124/dmd.109.027029

中图分类号：

R9 [药学];

学科分类号：

100702 [药剂学];

摘要：

Cytochrome P450 ( P450) induction is one of the factors that can affect the pharmacokinetics of a drug molecule upon multiple dosing, and it can result in pharmacokinetic drug-drug interactions with coadministered drugs causing potential therapeutic failures. In recent years, various in vitro assays have been developed and used routinely to assess the potential for drug-drug interactions due to P450 induction. There is a desire from the pharmaceutical industry and regulatory agencies to harmonize assay methodologies, data interpretation, and the design of clinical drug-drug interaction studies. In this article, a team of 10 scientists from nine Pharmaceutical Research and Manufacturers of America (PhRMA) member companies conducted an anonymous survey among PhRMA companies to query current practices with regards to the conduct of in vitro induction assays, data interpretation, and clinical induction study practices. The results of the survey are presented in this article, along with reviews of current methodologies of in vitro assays and in vivo studies, including modeling efforts in this area. A consensus recommendation regarding common practices for the conduct of P450 induction studies is included.

引用

页码：1339 / 1354

页数：16

共 118 条

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Pharmacokinetics and effect an caffeine metabolism of the proton pump inhibitors, omeprazole, lansoprazole, and pantoprazole [J].