Scientific white paper on concentration-QTc modeling-Reference-Cited by-同舟云学术

Scientific white paper on concentration-QTc modeling

Published:2017-12-05 Issue:3 Volume:45 Page:383-397
ISSN:1567-567X
Container-title:Journal of Pharmacokinetics and Pharmacodynamics
language:en
Short-container-title:J Pharmacokinet Pharmacodyn

Author:

Garnett Christine^ORCID,Bonate Peter L.,Dang Qianyu,Ferber Georg,Huang Dalong,Liu Jiang,Mehrotra Devan,Riley Steve,Sager Philip,Tornoe Christoffer,Wang Yaning

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

http://link.springer.com/article/10.1007/s10928-017-9558-5/fulltext.html

Reference40 articles.

1. ICH E14 Guideline (2015) The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Questions & answers (R3). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf

2. ICH E14 Guideline (2005) The Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

3. Marshall SF et al (2016) Good practices in model-informed drug discovery and development: practice, application, and documentation. CPT Pharm Syst Pharmacol 5(3):93–122

4. Ferber G, Zhou M, Darpo B (2015) Detection of QTc effects in small studies—implications for replacing the thorough QT study. Ann Noninvasive Electrocardiol 20(4):368–377

5. Garnett CE et al (2012) Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects. Am Heart J 163(6):912–930

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