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Designing pharmacogenetic projects in industry: practical design perspectives from the Industry Pharmacogenomics Working Group

Bromley, C M and Close, S and Cohen, N and Favis, R and Fijal, B and Gheyas, F and Liu, W and Lopez-Correa, C and Prokop, A and Singer, Jonathan and Snapir, A and Tchelet, A and Wang, D and Goldstaub, D (2009) Designing pharmacogenetic projects in industry: practical design perspectives from the Industry Pharmacogenomics Working Group. Pharmacogenomics Journal, 9 (1). pp. 14-22. ISSN 1473-1150

Abstract

Pharmacogenetic association studies have the potential to identify variations in DNA sequence which impact drug response. Identifying these DNA variants can help to explain interindividual variability in drug response; this is the first step in personalizing dosing and treatment regimes to a patient's needs. There are many intricacies in the design and analysis of pharmacogenetic association studies, including having adequate power, selecting proper endpoints, detecting and correcting the effects of population stratification, modeling genetic and nongenetic covariates accurately, and validating the results. At this point there are no formal guidelines on the design and analysis of pharmacogenetic studies. The Industry Pharmacogenomics Working Group has initiated discussions regarding potential guidelines for pharmacogenetic study design and analyses (http://i-pwg.org) and the results from these discussions are presented in this paper.

Item Type: Article
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Additional Information: Author can archive post-print (ie final draft post-refereeing); Publisher's version/PDF cannot be used
Keywords: pharmacogenetics; study design; clinical trial; statistical analysis
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Date Deposited: 22 Feb 2010 11:50
Last Modified: 22 Feb 2010 11:50
URI: https://oak.novartis.com/id/eprint/1645

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