A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study
Author:
Affiliation:
1. Gilead Sciences; Foster City California USA
2. Certara; St. Louis Missouri USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Reference13 articles.
1. ICH Harmonized Tripartite Guideline E14. 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 2014
2. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review;Garnett;J. Clin. Pharmacol.,2008
3. Population pharmacokinetic and concentration--QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies;Florian;J. Clin. Pharmacol.,2011
4. Early QT assessment--how can our confidence in the data be improved?;Darpo;Br. J. Clin. Pharmacol.,2013
5. The IQ-CSRC prospective clinical phase 1 study: “Can early QT assessment using exposure response analysis replace the thorough QT study?”;Darpo;Ann. Noninvasive Electrocardiol.,2014
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