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 guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b

Consultation dates: 28/08/2020 to 28/11/2020Draft: consultation closedReference Number: EMA/CHMP/ICH/415588/2020

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

AdoptedLegal effective date: 01/11/2005Reference Number: CHMP/ICH/2/04

Overview of comments received on ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers (EMA/CHMP/ICH/415588/2020)

Reference Number: EMA/658070/2020