JSM 2003 Online Program

Abstract #301042

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Activity Number:	5
Type:	Invited
Date/Time:	Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #301042
Title:	Multiplicity Considerations in Preclinical Evaluations
Author(s):	Joseph F. Heyse*+
Companies:	Merck Research Laboratories
Address:	PO Box 4, West Point, PA, 19486-0004,
Keywords:	multiplicity ; safety endpoints
Abstract:	The preclinical safety evaluation of pharmaceutical candidates involves performing a statistical analysis on each of many endpoints. This type of multiplicity consideration needs to be dealt with in carcinogenicity, pathology/toxicology, and development toxicology studies. It is important to understand the extent to which this multiplicity affects the probability of a false positive conclusion. Methods to deal with multiplicity need to be applied in this setting. This paper will review the various approaches that have been proposed for handling multiplicity in preclinical safety studies. The potential application of false discovery methods will also be discussed.

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