Display Settings:

Format

Send to:

Choose Destination
Pharmacogenomics. 2010 Dec;11(12):1669-75. doi: 10.2217/pgs.10.141.

Development and regulatory strategies for drug and diagnostic co-development.

Author information

  • 1Novartis Pharmaceuticals Corp., East Hanover, NJ 07939-1080, USA. lois.hinman@novartis.com

Abstract

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.

PMID:
21142909
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon
    Loading ...
    Write to the Help Desk