ICH updates E14/S7B (R1) Q&As on the evaluation of QT/QTc interval prolongation
ICH has published the revised E14/S7B (R1) Questions & Answers. The document clarifies the clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic risk.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the revised ICH E14/S7B Questions & Answers (R1). The document clarifies details of the clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic risk and complements the ICH E14 guideline (clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs) and the ICH S7B guideline (nonclinical evaluation of the potential for delayed ventricular repolarisation by human pharmaceuticals). It provides clarifications on ECG methodology, study design, concentration–response modelling and best practices for in vitro and in vivo nonclinical studies.
This review was prepared for the News section of the journal «Oʻzbekiston farmatsevtik xabarnomasi» (Pharmaceutical Bulletin of Uzbekistan).
Source: www.ich.org