Literature DB >> 22999322

Practice and challenges of thorough QT studies.

Norman Stockbridge1, Joanne Zhang, Christine Garnett, Marek Malik.   

Abstract

The drug-induced Torsade de Pointes (TdP) tachycardia is a known regulatory problem which led to the concept of the so-called thorough QT (TQT) studies now required for practically every new pharmaceutical compound. This review summarizes the concept of the TQT studies, their statistical evaluation, and related pharmacodynamic /pharmacokinetic modeling. The review also lists suggestions of how to make TQT studies more efficient and how to improve the interpretation of clinical data obtained during drug development to identify drugs prone to TdP induction more effectively.
Copyright © 2012 Elsevier Inc. All rights reserved.

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Year:  2012        PMID： 22999322     DOI： 10.1016/j.jelectrocard.2012.07.020

Source DB:  PubMed          Journal:  J Electrocardiol        ISSN： 0022-0736            Impact factor:   1.438


  9 in total

Review 1.  Early QT assessment--how can our confidence in the data be improved?

Authors:  Borje Darpo; Christine Garnett
Journal:  Br J Clin Pharmacol       Date:  2013-11       Impact factor: 4.335

Review 2.  Nomenclature, categorization and usage of formulae to adjust QT interval for heart rate.

Authors:  Simon W Rabkin; Xin Bo Cheng
Journal:  World J Cardiol       Date:  2015-06-26

Review 3.  Drug-Induced QT/QTc Interval Shortening: Lessons from Drug-Induced QT/QTc Prolongation.

Authors:  Marek Malik
Journal:  Drug Saf       Date:  2016-07       Impact factor: 5.606

4.  Azithromycin, cardiovascular risks, QTc interval prolongation, torsade de pointes, and regulatory issues: A narrative review based on the study of case reports.

Authors:  Jules C Hancox; Mehrul Hasnain; W Victor R Vieweg; Ericka L Breden Crouse; Adrian Baranchuk
Journal:  Ther Adv Infect Dis       Date:  2013-10

5.  Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium.

Authors:  Eunjung Park; Gary A Gintant; Daoqin Bi; Devi Kozeli; Syril D Pettit; Jennifer B Pierson; Matthew Skinner; James Willard; Todd Wisialowski; John Koerner; Jean-Pierre Valentin
Journal:  Br J Pharmacol       Date:  2018-01-15       Impact factor: 8.739

Review 6.  Integrating cardiomyocytes from human pluripotent stem cells in safety pharmacology: has the time come?

Authors:  Luca Sala; Milena Bellin; Christine L Mummery
Journal:  Br J Pharmacol       Date:  2016-09-20       Impact factor: 8.739

Review 7.  Modeling and Simulation Approaches for Cardiovascular Function and Their Role in Safety Assessment.

Authors:  T A Collins; L Bergenholm; T Abdulla; Jwt Yates; N Evans; M J Chappell; J T Mettetal
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2015-03-11

Review 8.  Top-down, Bottom-up and Middle-out Strategies for Drug Cardiac Safety Assessment via Modeling and Simulations.

Authors:  Zofia Tylutki; Sebastian Polak; Barbara Wiśniowska
Journal:  Curr Pharmacol Rep       Date:  2016-04-05

9.  Effect of ulixertinib, a novel ERK1/2 inhibitor, on the QT/QTc interval in patients with advanced solid tumor malignancies.

Authors:  Boaz Mendzelevski; Georg Ferber; Filip Janku; Bob T Li; Ryan J Sullivan; Dean Welsch; Wei Chi; Jeanne Jackson; Onglee Weng; Philip T Sager
Journal:  Cancer Chemother Pharmacol       Date:  2018-03-30       Impact factor: 3.333
  9 in total

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