JSM 2011 Online Program

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Abstract Details

Activity Number: 423
Type: Contributed
Date/Time: Tuesday, August 2, 2011 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301596
Title: Using Z-Prime Factor as Quantitative Measure of In Vivo PD Assay Quality
Author(s): Winnie Weng*+ and Guang Chen and Margaret Weidner and Kathy Keegan and Christophe Queva
Companies: Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc.
Address: 1201 Amgen CT W, Seattle, WA, 98119,
Keywords: z prime factor ; PD assay ; pharmacodynamic assay ; in vivo
Abstract:

In vivo pharmacodynamic (PD) assays have been used extensively in preclinical studies of drug development. They are used to develop a correlation between the mechanism of action of a drug with its desired efficacious outcome. To date, in vivo screening assays are evaluated independently without a standard method to compare one to another. Here we present the development of Z prime factor; a simple statistical parameter reflecting the combined effect of width of the assay window (i.e. difference between positive and negative controls), variation associated with assay, and number of animal and/or technical replicates used. Using Z prime factor as a quantitative measure of in vivo PD Assay quality, investigators can determine if the assay is sensitive enough for drug compound screening, as well as to estimate the fewest number of animals needed to achieve statistically significance, and to compare quality of different assay platforms.


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