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Activity Number: 280
Type: Contributed
Date/Time: Tuesday, August 4, 2009 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303858
Title: Marking the Ends of T-Waves: Algorithms and Experts
Author(s): Yingchun Zhou*+ and Nell Sedransk
Companies: National Institute of Statistical Sciences and National Institute of Statistical Sciences
Address: 19 Alexander Drive, Research Triangle Park, NC, 27709,
Keywords: ECG T-wave ; QT interval ; Bayesian algorithm ; cardiac safety
Abstract:

Prolongation of QT interval on electrocardiogram (ECG) is the current measure for cardiac safety used in drug development and drug approval. Pharmaceutical companies rely on software selection and then expert marking to determine the QT interval from thousands of beats. Not only is this costly, but selected beats of data also show that the difference between two experts' marks can exceed the tolerance level for beat differences that affect whether a drug gets approved or not. A Bayesian approach combines slope and curvature information for the (asymmetric) T-wave. The difference between these Bayesian marks and either of the experts' marks is not statistically larger than the difference between two experts' marks. Thus this approach succeeds in closely approximating experts' results in marking the T-wave end; it is fast, cost efficient, and consistent.


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