ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - questions and answers

This guideline concerns the clinical evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products. It addresses the electrocardiograms methodology, gender, positive control, study design, use of concentration response modeling of QTc data and electrocardiogram monitoring in late stage clinical trials.

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