A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study-Reference-Cited by-同舟云学术

A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study

Published:2015-09-29 Issue:6 Volume:98 Page:630-638
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Nelson CH¹,Wang L¹,Fang L¹,Weng W¹,Cheng F¹,Hepner M¹,Lin J¹,Garnett C²,Ramanathan S¹

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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