JSM 2011 Online Program

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Abstract Details

Activity Number: 627
Type: Contributed
Date/Time: Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302772
Title: Statistical Evaluation of an In Vitro Screening Assay to Assess Cardiac Liabilities of Emerging Drugs
Author(s): Lei Shu*+ and Gary Gintant and Thomas C. Lin
Companies: Abbott Laboratories and Abbott Laboratories and Abbott Laboratories
Address: 100 Abbott Park Road, Abbott Park, IL, 60064,
Keywords: Cardiac liability ; Contractility ; Electrical activity ; Equivalence test ; Preclinical screening ; Repeated measures ANOVA
Abstract:

Preclinical screening of potential drug-induced cardiac liabilities remains a critical part in the selection of drug candidates for clinical development. A functional in vitro assay was developed to assess compounds for cardiac repolarization and inotropic liabilities. Using this assay, changes in electrical activity (EA) and contractility can be measured to assess the risk of drug-induced cardiac liabilities. Repeated measures ANOVA model with between time points correlation ARH1 (heterogeneous first order autoregressive) was used to analyze the EA and contractility data collected by this assay. An equivalence test based on the model output was performed to determine if any statistically significant differences between drug and control detected by the model can be considered to be equivalent within a reasonable biological equivalence margin. This margin was determined by simulations on a historical control database to control the type-1 error rate at an appropriate level. Computer programs developed in SAS and R allow for quick delivery of statistical results in various report formats to support drug screening decision making.


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