Development and regulatory strategies for drug and diagnostic co-development

被引：7
|
作者：
Hinman, Lois M. [1 ]
Carl, Kevin M.
Spear, Brian B.
Salerno, Ronald A.
Becker, Robert L.
Abbott, Brian M.
Kelly, James F.
Mansfield, Elizabeth
Katz, Russell G.
Harper, Courtney
Day, Stephen P.
Pacanowski, Michael A.
Pignato, William [2 ]
机构：
[1] Novartis Pharmaceut, E Hanover, NJ 07939 USA
[2] Novartis Mol Diagnost, Cambridge, MA USA
来源：
PHARMACOGENOMICS | 2010年 / 11卷 / 12期
关键词：
biomarkers; co-development pharmacogenomics; companion diagnostics; drug/diagnostic; LUMIRACOXIB;
D O I：
10.2217/PGS.10.141
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit risk paradigm for new drugs.
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页码：1669 / 1675
页数：7
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