ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/423/02
Effective from01/11/2005
KeywordsDelayed ventricular repolarization, QT interval prolongation, non-clinical, risk assessment, electrophysiology studies
DescriptionThis 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.

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