4th US FDA-Drug Information Association pharmacogenomics workshop, held 10-12 December, 2007

被引：3

作者：

Frueh, Felix W. ^{[1
,2
]}

Salerno, Ronald A. ^{[3
]}

Lesko, Lawrence J. ^{[2
]}

Hockett, Richard D. ^{[4
]}

机构：

[1] Medco Hlth Solut Inc, Gaithersburg, MD 20878 USA

[2] US FDA, Off Clin Pharmacol, Silver Spring, MD USA

[3] Biol Consulting Grp Inc, Alexandria, VA USA

[4] Eli Lilly & Co, Indianapolis, IN 46285 USA

来源：

PHARMACOGENOMICS | 2009年 / 10卷 / 01期

关键词：

biomarkers; drug development; regulatory decision making;

D O I：

10.2217/14622416.10.1.111

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The 4th US FDA/Industry workshop, in a series on Pharmacogenomics, was on 'Biomarkers and Pharmacogenomics in Drug Development and Regulatory Decision Making' and was held on December 10-12, 2007 in Bethesda, MD, USA, with clear objectives to continue the dialogue that began in 2002 for enabling the use of biomarkers and pharmacogenomics in drug development and regulatory decision-making. This brief commentary will highlight the major topics and outcomes discussed at this meeting that was jointly sponsored by the FDA, The Pharmacogenomics Working Group (PWG), The Pharmaceutical Research and Manufacturers of America (PhRMA), The Biotechnology industry Organization (BIO) and The Drug Information Association (DIA).

引用

页码：111 / 115

页数：5