Comparison of validity of standard nonclinical group size selection versus standard clinical group sizes for nonhuman primate QTc prolongation evaluation-Reference-Cited by-同舟云学术

Comparison of validity of standard nonclinical group size selection versus standard clinical group sizes for nonhuman primate QTc prolongation evaluation

Published:2023-03 Issue: Volume:120 Page:107253
ISSN:1056-8719
Container-title:Journal of Pharmacological and Toxicological Methods
language:en
Short-container-title:Journal of Pharmacological and Toxicological Methods

Author:

Holdsworth David,Best Derek D.,Haist Katarina,O'Donohue Kyle,Phillips Anson,Abernathy Matthew M.,Roche Brian,Leishman Derek J.

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference20 articles.

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3. ICH_E14-S7B Training Material Examples Supplemental File 2022_0331.pdf;Anonymous,2022

4. ICH E14 guideline: the clinical evaluation of QT/QTc interval prolongation and Proarrhythmic potential for non-antiarrhythmic drugs - Questions & Answers;Anonymous.,2015

5. ICH E14/S7B implementation working group - clinical and nonclinical evaluation of QT/QTc interval prolongation and Proarrhythmic potential. Questions and Answers;Anonymous.,2022

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4. Comparing the sensitivity of cross-over and parallel study designs for QTc assessment: An analysis based on a single large study of moxifloxacin in 48 nonhuman primates;Journal of Pharmacological and Toxicological Methods;2023-09

5. The New S7B/E14 Q&A Document Provides Additional Opportunities to Replace the Thorough QT Study;The Journal of Clinical Pharmacology;2023-08-02