Abstract #300502

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JSM 2003 Abstract #300502
Activity Number: 256
Type: Luncheons
Date/Time: Tuesday, August 5, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300502
Title: Pharmacogenomics/Pharmacogenetics Studies in Drug Review
Author(s): Sue-Jane Wang*+
Companies: Food and Drug Administration
Address: CDER, 5600 Fishers Lane, Rockville, MD, 20857-0001,
Keywords: pharmacogenomics ; pharmacogenetics ; drug review
Abstract:

Advances in genomics have highlighted the importance of pharmacogenomic and pharmacogenetic approaches to drug discovery, drug development, and disease diagnosis. We shall discuss various aspects of the PGx/PGt studies when used in support of drug approval or further evaluation of safety concern. The goal is to raise the awareness of statisticians' role in this endeavor.


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Revised March 2003