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Search results with tag "Proarrhythmic"
Guideline on strategies to identify and mitigate risks for ...
www.ema.europa.eu• Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non - antiarrhythmic drugs (ICH E14) and related Q&A document. • Evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 Rev.4). • Guideline on clinical evaluation of new vaccines (EMEA/ CHMP/VWP/164653/05).
ICH E14/S7B Implementation Working Group: Clinical and ...
database.ich.orgClinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers Draft version Endorsed 27 August 2020 Note: This document for public consultation comprises of: Revisions proposed to sections 5.1 and 6.1 of the current Q&As for ICH E14. Other sections are not proposed for revision.