Study Design and Statisical Evaluation of QT Designs
Statistical Method for the Evaluation of QT Prolongation Effects in Thorough QT Study
2008 Volume 29 Issue Special_Issue_1 Pages S83-S96
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2008 Volume 29 Issue Special_Issue_1 Pages S83-S96
Thorough QT/QTc study is suggested by the ICH E14 guideline as one of the core components in evaluating the effect of the study drug on QT interval. This article gives an explanation for the analysis of QT/QTc data from thorough QT/QTc studies, presents some statistical issues associated with the analysis and provides some recommendations on how to handle those issues.
