ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline
Table of contents
This document describes a non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. It includes information concerning non-clinical assays and integrated risk assessment.
Keywords: Delayed ventricular repolarization, QT interval prolongation, non-clinical, risk assessment, electrophysiology studies
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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: S 7 B: The nonclinical evaluation of the potential for delayed Ventricular Repolarization (QT Interval Prolongation) by human pharmaceuticals - Step 5 (PDF/216.71 KB)
Adopted
First published: 31/05/2005
Last updated: 31/05/2005
Legal effective date: 01/11/2005
CPMP/ICH/423/02 -
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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 -
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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) (PDF/743.66 KB)
First published: 08/12/2020
EMA/658070/2020