Literature DB >> 24397828

The thorough QT study: Is its demise on the horizon?

Philip T Sager1, Peter Kowey.   

Abstract

Mesh：

Year:  2014        PMID： 24397828      PMCID： PMC6932450          DOI： 10.1111/anec.12127

Source DB:  PubMed          Journal:  Ann Noninvasive Electrocardiol        ISSN： 1082-720X            Impact factor:   1.468


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  9 in total

Review 1.  Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.

Authors:  Christine E Garnett; Nhi Beasley; V Atul Bhattaram; Pravin R Jadhav; Rajanikanth Madabushi; Norman Stockbridge; Christoffer W Tornøe; Yaning Wang; Hao Zhu; Jogarao V Gobburu
Journal:  J Clin Pharmacol       Date:  2008-01       Impact factor: 3.126

Review 2.  The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

Authors:  Borje Darpo; Nenad Sarapa; Christine Garnett; Charles Benson; Corina Dota; Georg Ferber; Venkateswar Jarugula; Lars Johannesen; James Keirns; Kevin Krudys; Catherine Ortemann-Renon; Steve Riley; Danise Rogers-Subramaniam; Norman Stockbridge
Journal:  Ann Noninvasive Electrocardiol       Date:  2013-12-30       Impact factor: 1.468

3.  Revolution dawning in cardiotoxicity testing.

Authors:  Kelly Rae Chi
Journal:  Nat Rev Drug Discov       Date:  2013-08       Impact factor: 84.694

4.  Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability.

Authors:  Marek Malik; Joanne Zhang; Lars Johannesen; Katerina Hnatkova; Christine Garnett
Journal:  Heart Rhythm       Date:  2011-06-16       Impact factor: 6.343

Review 5.  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 6.  Dealing with global safety issues : was the response to QT-liability of non-cardiac drugs well coordinated?

Authors:  Norman Stockbridge; Joel Morganroth; Rashmi R Shah; Christine Garnett
Journal:  Drug Saf       Date:  2013-03       Impact factor: 5.606

Review 7.  Key clinical considerations for demonstrating the utility of preclinical models to predict clinical drug-induced torsades de pointes.

Authors:  P T Sager
Journal:  Br J Pharmacol       Date:  2008-06-09       Impact factor: 8.739

8.  Screening drug-induced arrhythmia [corrected] using human induced pluripotent stem cell-derived cardiomyocytes and low-impedance microelectrode arrays.

Authors:  Enrique G Navarrete; Ping Liang; Feng Lan; Verónica Sanchez-Freire; Chelsey Simmons; Tingyu Gong; Arun Sharma; Paul W Burridge; Bhagat Patlolla; Andrew S Lee; Haodi Wu; Ramin E Beygui; Sean M Wu; Robert C Robbins; Donald M Bers; Joseph C Wu
Journal:  Circulation       Date:  2013-09-10       Impact factor: 29.690

9.  Simulation of multiple ion channel block provides improved early prediction of compounds' clinical torsadogenic risk.

Authors:  Gary R Mirams; Yi Cui; Anna Sher; Martin Fink; Jonathan Cooper; Bronagh M Heath; Nick C McMahon; David J Gavaghan; Denis Noble
Journal:  Cardiovasc Res       Date:  2011-02-07       Impact factor: 10.787
  9 in total
  2 in total

1.  ICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies.

Authors:  Rashmi R Shah; Joel Morganroth; Robert B Kleiman
Journal:  Br J Clin Pharmacol       Date:  2015-03       Impact factor: 4.335

2.  QT interval variations and mortality risk: is there any relationship?

Authors:  Ciprian Rezuş; Victor Dan Moga; Anca Ouatu; Mariana Floria
Journal:  Anatol J Cardiol       Date:  2015-03       Impact factor: 1.596
  2 in total

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