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

This guideline 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.

Keywords: QT/QTc interval prolongation, proarrhythmic potential, noncardiovascular drugs, thorough QT/QTc study, concentration-response modeling

Current version

ICH: E 14: The Clinical Evaluation of QT/QTs Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic drugs - Step 5

AdoptedReference Number: CHMP/ICH/2/04Legal effective date: 01/11/2005