Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As

Author:

Rossman Eric I.,Wisialowski Todd A.,Vargas Hugo M.,Valentin Jean-Pierre,Rolf Michael G.,Roche Brian M.,Riley Steve,Pugsley Michael K.,Nichols Jill,Li Dingzhou,Leishman Derek J.,Kleiman Robert B.,Greiter-Wilke Andrea,Gintant Gary A.,Engwall Michael J.,Delaunois Annie,Authier Simon

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference56 articles.

1. ICH E14/S7B Implementation Working Group: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers;Anonymous,2022

2. ICH E14/S7B implementation working group: E14/S7B questions and answers: Clinical and nonclinical evaluation of QT/QTc interval prolongation and Proarrhythmic potential. Training Materials;Anonymous,2022

3. Evaluation of a novel ECG lead placement method in telemetered freely moving cynomolgus monkeys: Assessment of an intravascular biopotential lead;Authier;Journal of Pharmacological and Toxicological Methods,2011

4. Review of the statistical analysis of the dog telemetry study;Aylott;Pharmaceutical Statistics,2011

5. 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;Baublits;Journal of Pharmacological and Toxicological Methods,2021

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