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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Veröffentlicht in:	Japanese Journal of Biometrics 2008/07/01, Vol.29(Special_Issue_1), pp.S83-S96
Hauptverfasser:	Satoi, Yoichi, Uesaka, Hiroyuki
Format:	Artikel
Sprache:	eng ; jpn
Schlagworte:	ICH E14 guideline Multiplicity Sample size Thorough QT/QTc study
Online-Zugang:	Volltext
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Zusammenfassung:	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