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Activity Number:
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572
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Type:
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Contributed
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Date/Time:
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Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305174 |
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Title:
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Determination of Sample Size for Validation Study in Pharmacogenomics
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Author(s):
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Youlan Rao*+ and Yoonkyung Lee and Jason Hsu
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Companies:
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The Ohio State University and The Ohio State University and The Ohio State University
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Address:
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, , ,
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Keywords:
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sample size ; sensitivity ; specificity ; microarray ; change of platform ; pharmacogenomics
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Abstract:
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Pharmacogenomics aims at co-development of a drug that targets a subgroup of patients with efficacy and a device that identifies the responder group through patients' genetic variations. Development of such a prognostic device includes a training stage and a validation stage. The transition from the training stage to the validation stage typically involves change of platforms as a subset of the genes predictive of drug response are identified in the first stage and only those are used in the second stage. With the change in consideration, this paper concerns how to determine sample sizes for the validation stage to meet pre-specified sensitivity and specificity requirements in order to avoid futility of pharmacogenomic development. The change of platforms is taken into account in the sample sizes calculation by linear mixed effect modeling.
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