Utility of positive controls in assessing assay sensitivity in ICH S7B and ICH E14 guidance for evaluation of QT/QTc interval prolongation-Reference-Cited by-同舟云学术

Utility of positive controls in assessing assay sensitivity in ICH S7B and ICH E14 guidance for evaluation of QT/QTc interval prolongation

Published:2010-09 Issue:2 Volume:62 Page:143-147
ISSN:1056-8719
Container-title:Journal of Pharmacological and Toxicological Methods
language:en
Short-container-title:Journal of Pharmacological and Toxicological Methods

Author:

Chiang Alan Y.,Mallinckrodt Craig H.,Dmitrienko Alex A.,Leishman Derek J.

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference12 articles.

1. ILSI-HESI Cardiovascular Safety Subcommittee Dataset: An analysis of the statistical properties of QT interval and rate corrected QT interval (QTc);Chiang;Journal of Pharmacological and Toxicological Methods,2007

2. A one-step approach to the analysis of the QT interval in safety pharmacology studies;Chiang;Journal of Pharmacological and Toxicological Methods,2006

3. Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs;ICH E14 Guidance,2005

4. Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs: Questions and answers;ICH E14 Guidance,2008

5. Safety pharmacology studies for human pharmaceuticals;ICH S7A Guidance,2001

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. 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;Journal of Pharmacological and Toxicological Methods;2021-05

2. Pharmacokinetic-pharmacodynamic modelling of drug-induced QTc interval prolongation in man: prediction fromin vitrohuman ether-à-go-go-related gene binding and functional inhibition assays and conscious dog studies;British Journal of Pharmacology;2016-09-07

3. The Antibody Targeting the E314 Peptide of Human Kv1.3 Pore Region Serves as a Novel, Potent and Specific Channel Blocker;PLoS ONE;2012-04-27

4. Non-clinical models: Validation, study design and statistical consideration in safety pharmacology;Journal of Pharmacological and Toxicological Methods;2010-07