Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute-Reference-Cited by-同舟云学术

Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute

Published:2023-05 Issue: Volume:121 Page:107265
ISSN:1056-8719
Container-title:Journal of Pharmacological and Toxicological Methods
language:en
Short-container-title:Journal of Pharmacological and Toxicological Methods

Author:

Vargas Hugo M.,Rossman Eric I.,Wisialowski Todd A.,Nichols Jill,Pugsley Michael K.,Roche Brian,Gintant Gary A.,Greiter-Wilke Andrea,Kleiman Robert B.,Valentin Jean-Pierre,Leishman Derek J.

Funder

Pharmaceutical Research and Manufacturers of America Foundation

Amgen

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference43 articles.

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1. Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document;Journal of Pharmacological and Toxicological Methods;2023-09

2. 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;Journal of Pharmacological and Toxicological Methods;2023-09