Highly Automated QT Measurement Techniques in 7 Thorough QT Studies Implemented under ICH E14 Guidelines

• Published in: Annals of noninvasive electrocardiology Vol. 16; no. 1; pp. 13 - 24
• Main Authors: Couderc, Jean-Philippe, Garnett, Christine, Li, Mike, Handzel, Robert, McNitt, Scott, Xia, Xiajuan, Polonsky, Slava, Zareba, Wojciech
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.01.2011
• Subjects: Anti-Infective Agents - pharmacology; Aza Compounds - pharmacology; Cardiotoxins; drug cardiotoxicity; Drug Evaluation, Preclinical; drug safety; electrocardiogram; Electrocardiography; Female; Fluoroquinolones; Guidelines as Topic; Heart Conduction System - drug effects; Humans; Long QT Syndrome - chemically induced; Male; Models, Biological; Moxifloxacin; Neuromuscular Nondepolarizing Agents - administration & dosage; Original; QT interval; Quinolines - pharmacology; Sex Factors; thorough QT study

Thorough QT (TQT) studies are designed to evaluate potential effect of a novel drug on the ventricular repolarization process of the heart using QTc prolongation as a surrogate marker for torsades de pointes. The current process to measure the QT intervals from the thousands of electrocardiograms is...