The QT interval of the electrocardiogram (ECG) is a measure of the duration of ventricular depolarization and repolarization. QT interval prolongation can be caused by certain medicines. When ventricular repolarization is delayed and the QT interval is prolonged, there is an increased risk of ventricular tachyarrhythmia, including torsade de pointes, particularly when combined with other risk factors (e.g., hypokalaemia, structural heart disease, bradycardia). Thus, medicines are tested for their potential proarrhythmic effects at various stages of drug development, following this ICH guidance document which includes information concerning non-clinical assays and integrated risk assessment principles to be applied.
Please read in conjunction with the dedicated question and answer document on ICH guideline E14/S7B
Keywords: Delayed ventricular repolarization, QT interval prolongation, non-clinical, risk assessment, electrophysiology studies