ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/ICH/2/04
Published01/11/2005
Effective from01/11/2005
KeywordsQT/QTc interval prolongation, proarrhythmic potential, noncardiovascular drugs, thorough QT/QTc study, concentration-response modeling
DescriptionThis document provides recommendations on the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. Read together with questions and answers.


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