Thorough QT (TQT) studies: concordance with torsadogenesis and an evolving cardiac safety testing paradigm.

Authors :: Wiśniowska B
Tylutki Z
Polak S
Source :: Drug discovery today [Drug Discov Today] 2017 Oct; Vol. 22 (10), pp. 1460-1465. Date of Electronic Publication: 2017 May 13.
Publication Year :: 2017
Abstract: Since 2005, when the International Conference on Harmonisation (ICH) E14 guideline was adopted, no drug has been withdrawn because of QTc prolongation or torsade de pointes arrhythmia. There are, however, costs associated with this success. In addition to the time and money invested, thorough QT (TQT) studies have limited the efficiency of the drug development pipeline. In this paper, we discuss the relevance of TQT trials as a tool for proarrhythmic risk prediction as a part of the debate regarding their usefulness.<br /> (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Subjects :: Arrhythmias, Cardiac drug therapy
Arrhythmias, Cardiac physiopathology
Drug Discovery methods
Heart drug effects
Humans
Long QT Syndrome drug therapy
Pharmaceutical Preparations administration & dosage
Heart physiopathology
Long QT Syndrome physiopathology

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