ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - questions and answers - Scientific guideline
Table of contents
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
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ICH guideline E14/S7B: clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential - questions and answers - Step 5 (PDF/389.61 KB)
Adopted
First published: 24/03/2022
Last updated: 29/03/2022
Legal effective date: 27/07/2022
EMA/CHMP/ICH/415588/2020 -
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ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answers - Step 5 (PDF/331.02 KB)
First published: 01/06/2008
Last updated: 01/02/2016
Legal effective date: 01/05/2012
EMEA/CHMP/ICH/310133/2008 -
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ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b (PDF/456.19 KB)
Draft: consultation closed
First published: 28/08/2020
Consultation dates: 28/08/2020 to 28/11/2020
EMA/CHMP/ICH/415588/2020