Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document

Author:

Pugsley Michael K.,Koshman Yevgeniya E.,Foley C. Michael,Winters Brett R.,Authier Simon,Curtis Michael J.

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference44 articles.

1. S7A safety pharmacology studies for human pharmaceuticals. International Council for Harmonisation of technical requirements for pharmaceuticals for human use;Anonymous;Federal Register,2001

2. ICH S7B: The non-clinical evaluation of the potential fro delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. International Council for Harmonisation of technical requirements for Pharmaceuticals for Human use;Anonymous;Federal Register,2005

3. ICH E14: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Internal Council for Harmonisation of technical requirements for Pharmaceuticals for Human use;Anonymous;Federal Register,2005

4. International multisite study of human-induced pluripotent stem cell-derived cardiomyocytes for drug proarrhythmic potential assessment;Blinova;Cell Reports,2018

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