Literature DB >> 25060671

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

Rashmi R Shah1, Joel Morganroth, Robert B Kleiman.   

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Year:  2015        PMID： 25060671      PMCID： PMC4345956          DOI： 10.1111/bcp.12477

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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  25 in total

1.  The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.

Authors:  J C Bouvy; M A Koopmanschap; R R Shah; H Schellekens
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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.  The thorough QT study: Is its demise on the horizon?

Authors:  Philip T Sager; Peter Kowey
Journal:  Ann Noninvasive Electrocardiol       Date:  2014-01-08       Impact factor: 1.468

4.  Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis.

Authors:  C Schmitt; B Kuhn; X Zhang; A J Kivitz; S Grange
Journal:  Clin Pharmacol Ther       Date:  2011-03-23       Impact factor: 6.875

5.  Gene-specific effects of inflammatory cytokines on cytochrome P450 2C, 2B6 and 3A4 mRNA levels in human hepatocytes.

Authors:  Alison E Aitken; Edward T Morgan
Journal:  Drug Metab Dispos       Date:  2007-06-18       Impact factor: 3.922

6.  Controlled trial of sotalol for one year after myocardial infarction.

Authors:  D G Julian; R J Prescott; F S Jackson; P Szekely
Journal:  Lancet       Date:  1982-05-22       Impact factor: 79.321

7.  Electrophysiologic effects of the levo- and dextrorotatory isomers of sotalol in isolated cardiac muscle and their in vivo pharmacokinetics.

Authors:  R Kato; N Ikeda; S M Yabek; R Kannan; B N Singh
Journal:  J Am Coll Cardiol       Date:  1986-01       Impact factor: 24.094

8.  Sotalol, hypokalaemia, syncope, and torsade de pointes.

Authors:  J K McKibbin; W A Pocock; J B Barlow; R N Millar; I W Obel
Journal:  Br Heart J       Date:  1984-02

9.  Dose-related effects of methadone on QT prolongation in a series of patients with torsade de pointes.

Authors:  Mori J Krantz; Ilana B Kutinsky; Alastair D Robertson; Philip S Mehler
Journal:  Pharmacotherapy       Date:  2003-06       Impact factor: 4.705

10.  Stereoselective Inhibition of the hERG1 Potassium Channel.

Authors:  Liliana Sintra Grilo; Pierre-Alain Carrupt; Hugues Abriel
Journal:  Front Pharmacol       Date:  2010-11-22       Impact factor: 5.810
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  5 in total

1.  Moxifloxacin-induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study.

Authors:  Joel Morganroth; Yaning Wang; Michael Thorn; Yuji Kumagai; Stuart Harris; Norman Stockbridge; Robert Kleiman; Rashmi Shah
Journal:  Br J Clin Pharmacol       Date:  2015-07-02       Impact factor: 4.335

2.  Evaluation of Index of Cardio-Electrophysiological Balance (iCEB) as a New Biomarker for the Identification of Patients at Increased Arrhythmic Risk.

Authors:  Tomas Robyns; Hua Rong Lu; David J Gallacher; Christophe Garweg; Joris Ector; Rik Willems; Stefan Janssens; Dieter Nuyens
Journal:  Ann Noninvasive Electrocardiol       Date:  2015-08-25       Impact factor: 1.468

3.  Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy.

Authors:  Ajai Chari; Markus Munder; Katja Weisel; Matthew Jenner; Ceri Bygrave; Maria Teresa Petrucci; Mario Boccadoro; Michele Cavo; Niels W C J van de Donk; Mehmet Turgut; Fatih Demirkan; Ihsan Karadogan; Edward Libby; Robert Kleiman; Steven Kuppens; Rajesh Bandekar; Tobias Neff; Christoph Heuck; Ming Qi; Pamela L Clemens; Hartmut Goldschmidt
Journal:  Adv Ther       Date:  2021-01-20       Impact factor: 3.845

4.  A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers.

Authors:  James V Cassella; Daniel A Spyker; Paul P Yeung
Journal:  Int J Clin Pharmacol Ther       Date:  2015-11       Impact factor: 1.366

Review 5.  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
  5 in total

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