Abstract Details
Activity Number:
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435
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Type:
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Contributed
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Date/Time:
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Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #315749
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View Presentation
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Title:
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Statistical Tests on Concentration-QTc Hysteresis
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Author(s):
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Kuenhi Tsai* and Li Fan and Fang Liu and Devan Mehrotra and Georg Ferber
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Companies:
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Merck and Merck and Merck and Merck and Statistical Consultant
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Keywords:
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QTc Prolongation ;
PK-QTc model
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Abstract:
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QTc prolongation assessment is critical to investigate the effects of drugs on cardiac repolarization in clinical studies. A drug effect on QT that is delayed compared to the plasma concentrations of the drug can impose a risk of inadequate evaluation or bias on the assessment, in particular if concentration-response models are used. Several statistical tests and PK/PD models have been developed to evaluate or estimate the hysteresis. In this presentation, we will show the results of evaluating the existing statistical tests as well as a newly proposed method using simulations. Furthermore, we will contrast the methods via application to two real data sets.
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Authors who are presenting talks have a * after their name.
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