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