JSM 2004 Online Program

Abstract #301394

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Activity Number:	123
Type:	Luncheons
Date/Time:	Monday, August 9, 2004 : 12:30 PM to 1:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #301394
Title:	Biomarkers and Their Validation in Pharmacogenomics - SOLD OUT
Author(s):	Sue-Jane Wang*+
Companies:	U.S. Food and Drug Administration
Address:	5600 Fishers Lane, Rockville, MD, 20857,
Keywords:	biomarker ; pharmacogenomics ; pharmacogenetics
Abstract:	The recent advances in genomics, such as gene expression and single neucleotide polymorphisms, and proteomics, such as, protein expression, opened the door for drug trials to investigate adaptively a potential single biomarker or composite biomarkers measured using noninvasive procedures for pharmacologic response and/or toxicity classifications. We shall discuss exploration of potential, probable biomakers and statistical/biological validations in the pharmacogenomics/pharmacogenetics studies when they are used as a scientific finding and/or for future drug trial design and evaluation of safety concern.

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