ICH Guideline E14/S7B: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Q&A Step 5

On 24 March 2022 the EMA published the ICH Q&A guideline E14/S7B.

This Q&A guideline concerns the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic medicinal products. It addresses the electrocardiogram methodology, gender, positive control, study design, use of concentration response modeling of QTc data and electrocardiogram monitoring in late stage clinical trials.

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