Statistical Method for the Evaluation of QT Prolongation Effects in Thorough QT Study

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 an...

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Bibliographic Details
Published inJapanese Journal of Biometrics Vol. 29; no. Special_Issue_1; pp. S83 - S96
Main Authors Satoi, Yoichi, Uesaka, Hiroyuki
Format Journal Article
LanguageEnglish
Japanese
Published The Biometric Society of Japan 2008
Subjects
ICH E14 guideline
Multiplicity
Sample size
Thorough QT/QTc study
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Summary: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.
ISSN:0918-4430
2185-6494
DOI:10.5691/jjb.29.S83