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This Q&A document complements the ICH E14 and ICH S7B guidelines to clarify multidisciplinary aspects related to the evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products. It addresses various aspects addressed in the two guidelines, including: electrocardiogram methodology, study design aspects including choice of positive control and monitoring provisions, use of concentration response-modeling, non-clinical integrated risk assessment, best practice considerations for in vitro and in vivo non-clinical studies.
Of note, this Q&A document integrates and replaces the previous ICH E14(R3) Q&A and the previous version of the ICH E14/S7B Q&A document (EMA version dated 24 March 2022). In view of the limited scope of the changes, this Q&A did not undergo a public consultation in the ICH regions.
Keywords: QT/QTc interval prolongation, proarrhythmic potential, noncardiovascular drugs, thorough QT/QTc study, concentration-response modelling, non-clinical