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Activity Number: 435
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #315749 View Presentation
Title: Statistical Tests on Concentration-QTc Hysteresis
Author(s): Kuenhi Tsai* and Li Fan and Fang Liu and Devan Mehrotra and Georg Ferber
Companies: Merck and Merck and Merck and Merck and Statistical Consultant
Keywords: QTc Prolongation ; PK-QTc model
Abstract:

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.


Authors who are presenting talks have a * after their name.

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