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Activity Number: 547
Type: Contributed
Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #308927
Title: Statistical Quantification of Drug-Related Arrhythmia
Author(s): Kai-Fen Wang*+ and Paul McAllister and Eric Rossman
Companies: GlaxoSmithKline and GlaxoSmithKline and GlaxoSmithKline
Keywords: Arrhythmias ; Cardiovascular safety ; Background ; Drug-induced ; Pattern based approach
Abstract:

Current methodologies, used to determine if arrhythmias are drug-induced in cardiovascular safety studies, often focus solely upon the comparison between pre- and post-dose quantities. However, due to the background incidence of arrhythmias in larger species (i.e. dog or monkey), these comparisons have proved to be quite difficult and frequently lead to inconclusive results. In lieu of this, we have recently created a statistical model using a pattern based approach, which can be used to differentiate between background and drug-induced ventricular arrhythmias in dogs.


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