SEARCH

SEARCH BY CITATION

References

  • 1
    Salvi V, Karnad DR, Panicker GK, Kothari S. Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development. Br J Pharmacol 2010; 159: 3448.
  • 2
    ICH E14. The Clinical Evaluation of QT/QTc Interval Prolongation and Pro-arrhythmic Potential for Non-antiarrhythmic Drugs. 2005. International Conference on Harmonisation Step 4 Guideline, EMEA, CHMP/ICH/2/04.25-5.
  • 3
    ICH Harmonized Tripartite Guideline E14. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 2012. International conference on harmonisation, E14 Implementation and working group, Question and Answers.
  • 4
    Florian JA, Tornøe CW, Brundage R, Parekh A, Garnett CE. Population pharmacokinetic and concentration–QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies. J Clin Pharmacol 2011; 51: 11521162.
  • 5
    Dixon R, Job S, Oliver R, Tompson D, Wright JG, Maltby K, Lorch U, Taubel J. Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects. Br J Clin Pharmacol 2008; 66: 396404.
  • 6
    Iwamoto M, Kost JT, Mistry GC, Wenning LA, Breidinger SA, Marbury TC, Stone JA, Gottesdiener KM, Bloomfield DM, Wagner JA. Raltegravir thorough QT/QTc study: a single supratherapeutic dose of raltegravir does not prolong the QTcF interval. J Clin Pharmacol 2008; 48: 726733.
  • 7
    Kubitza D, Mueck W, Becka M. Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation. Drug Saf 2008; 31: 6777.
  • 8
    Démolis JL, Kubitza D, Tennezé L, Funck-Brentano C. Effect of a single oral dose of moxifloxacin (400 mg and 800 mg) on ventricular repolarization in healthy subjects. Clin Pharmacol Ther 2000; 68: 658666.
  • 9
    Grosjean P, Urien S. Re-evaluation of moxifloxacin pharmacokinetics and their direct effect on the QT interval. J Clin Pharmacol 2012; 52: 329338.
  • 10
    Taubel J, Wong AH, Naseem A, Ferber G, Camm AJ. Shortening of the QT interval after food can be used to demonstrate assay sensitivity in thorough QT studies. J Clin Pharmacol 2012; 52: 15581565.
  • 11
    Taubel J, Lorch U, Ferber G, Singh J, Batchvarov V, Savelieva I, Camm AJ. Insulin at normal physiological levels does not prolong QTc interval in thorough QT studies performed in healthy volunteers. Br J Clin Pharmacol 2013; 75: 392403.
  • 12
    Bloomfield DM, Kost JT, Ghosh K, Hreniuk D, Hickey LA, Guitierrez MJ, Gottesdiener K, Wagner JA. The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther 2008; 84: 475480.
  • 13
    Lettieri J, Vargas R, Agarwal V, Liu P. Effect of food on the pharmacokinetics of a single oral dose of moxifloxacin 400 mg in healthy male volunteers. Clin Pharmacokinet 2001; 40: 1925.
  • 14
    Stass H, Kubitza D. Profile of moxifloxacin drug interactions. Clin Infect Dis 2001; 32: S4750.
  • 15
    Shah RR. Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter? Br J Clin Pharmacol 2013; 75: 347358.
  • 16
    Yu KS, Cho JY, Shon JH, Bae KS, Yi SY, Lim HS, Jang IJ, Shin SG. Ethnic differences and relationships in the oral pharmacokinetics of nifedipine and erythromycin. Clin Pharmacol Ther 2001; 70: 228236.
  • 17
    Sugiyama A, Nakamura Y, Nishimura S, Adachi-Akahane S, Kumagai Y, Gayed J, Naseem A, Ferber G, Taubel J, Camm C. Comparison of the effects of levofloxacin on QT/QTc interval assessed in both healthy Japanese and Caucasian subjects. Br J Clin Pharmacol 2012; 73: 455459.
  • 18
    Kang J, Wang L, Chen XL, Triggle DJ, Rampe D. Interactions of a series of fluoroquinolone antibacterial drugs with the human cardiac K+ channel HERG. Mol Pharmacol 2001; 59: 122126.
  • 19
    R Development Core Team. R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing, 2011; ISBN 3-900051-07-0. Available at http://www.R-project.org/ (last accessed 28 June 2013).
  • 20
    Taubel J, Ferber G, Naseem A, Camm AJ. Sex differences on the effect of moxifloxacin– a meta-analysis of five thorough qt studies. Jpn J Clin Pharm Ther 2011; (Suppl. 42): S288.
  • 21
    Yan LK, Zhang J, Ng MJ, Dang Q. Statistical characteristics of moxifloxacin-induced QTc effect. J Biopharm Stat 2010; 20: 497507.
  • 22
    Malik M, Hnatkova K, Schmidt A, Smetana P. Electrocardiographic Q. Tc changes due to moxifloxacin infusion. J Clin Pharmacol 2009; 49: 674683.
  • 23
    Galuska D, Pirkmajer S, Barrès R, Ekberg K, Wahren J, Chibalin AV. C-peptide increases Na,K-ATPase expression via PKC- and MAP kinase-dependent activation of transcription factor ZEB in human renal tubular cells. PLoS ONE 2011; 6: e28294.
  • 24
    Kumagai Y, Ikeda Y, Fujita T, Sahashi K, Saikawa T. Confirmation of QT prolongation by oral moxifloxacin in healthy Japanese subjects for Thorough QT/QTc studies in Japan. Basic Clin Pharmacol Toxicol 2011; 109: (Suppl. 1): 102.