Performance characteristics for some typical QT study designs under the ICH E-14 guidance.
J Clin Pharmacol. 2008 Feb;48(2):215-24
Filed Under:
Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation.
Drug Saf. 2008;31(1):67-77
Authors: Kubitza D, Mueck W, Becka M
Filed Under:
Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study.
Eur J Clin Pharmacol. 2007 Nov;63(11):1011-7
Filed Under:
Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuti
Filed Under:
Cardiac safety strategies. 25-26 October 2005, the Radisson SAS Hotel, Nice, France.
Expert Opin Drug Saf. 2006 Mar;5(2):329-33
Authors: Hanton G, Tilbury L
Filed Under:
International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice.
Fed Regist. 2005 Oct 20;70(202):61134-5
Authors:
Filed Under:
Drugs, QTc interval prolongation and final ICH E14 guideline : an important milestone with challenges ahead.
Drug Saf. 2005;28(11):1009-28
Authors: Shah RR
Filed Under:
Use of in vitro methods to predict QT prolongation.
Toxicol Appl Pharmacol. 2005 Sep 1;207(2 Suppl):446-50
Authors: Hammond TG, Pollard CE
Filed Under:
Strategies to reduce the risk of drug-induced QT interval prolongation: a pharmaceutical company perspective.
Br J Pharmacol. 2008 May 26;
Authors: Pollard CE, Valentin JP, Hammond TG
Filed Under:
The use of electrocardiograms in clinical trials: a public discussion of the proposed ICH E14 regulatory guidance. April 11-12, 2005, Bethesda, MD, USA.
Expert Opin Drug Saf. 2005 Jul;4(4):795-9
Authors: Cavero I, Crumb W
Filed Under:
