Overview of the ICH E14/S7B: Questions and Answers

Author:

Valentin By Jean-Pierre,Leishman Derek,Vargas Hugo

Publisher

Springer International Publishing

Reference49 articles.

1. Ando H, Yoshinaga T, Yamamoto W et al (2017) A new paradigm for drug-induced torsadogenic risk assessment using human iPS cell-derived cardiomyocytes. J Pharmacol Toxicol Methods 84:111–127. https://doi.org/10.1016/j.vascn.2016.12.003. Epub 2016 Dec 10. PMID: 27956204

2. Anon (2005a) ICH topic S7B the non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. International Council for Harmonization of technical requirements for Pharmaceuticals for Human use (ICH). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-7-b-nonclinical-evaluation-potential-delayed-ventricular-repolarization-qt-interval_en.pdf. Accessed 21 Jan 2024

3. Anon (2005b) ICH Topic E14: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. CPMP/ICH/2/04; 2005, London. http://www.emea.eu.int/pdfs/human/ich/00020 4en.pdf. Accessed 21 Jan 2024

4. Anon (2022) ICH E14/S7B Q&As. Clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential – questions and answers. February 2022 https://database.ich.org/sites/default/files/E14-S7B_QAs_Step4_2022_0221.pdf. Accessed 21 Jan 2024

5. Baublits J, Vargas HM, Engwall MJ (2021) The in vivo QTc core assay: an evaluation of QTc variability, detection sensitivity and implications for the improvement of conscious dog and non-human primate telemetry studies. J Pharmacol Toxicol Methods 109:107067. https://doi.org/10.1016/j.vascn.2021.107067. Epub 2021 Apr 20. Erratum in: J Pharmacol Toxicol Methods. 2021 Nov–Dec;112:107104. PMID: 33857614

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