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

AdoptedLegal effective date: Reference Number: 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

AdoptedLegal effective date: Reference Number: 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

Consultation dates: to Draft: consultation closedReference Number: 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)

Reference Number: EMA/658070/2020

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