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

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.

1. ICH E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non- antiarrhythmic drugs;Anonymous,2005

2. ICH S7B: The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals;Anonymous,2005

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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