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

Keywords: QT/QTc interval prolongation, proarrhythmic potential, noncardiovascular drugs, thorough QT/QTc study, concentration-response modeling

Documents

ICH guideline E14/S7B: clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential - questions and answers - Step 5

AdoptedLegal effective date: Reference Number: EMA/CHMP/ICH/415588/2020

English (EN) (389.61 KB - PDF)

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ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answers - Step 5

Legal effective date: Reference Number: EMEA/CHMP/ICH/310133/2008

English (EN) (331.02 KB - PDF)

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ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b

Consultation dates: to Draft: consultation closedReference Number: EMA/CHMP/ICH/415588/2020

English (EN) (456.19 KB - PDF)

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