SEARCH

SEARCH BY CITATION

References

  • 1
    Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007; 102(9):20362045.
  • 2
    European Medicines Agency. Motilium Summary of Product Characteristics. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Motilium/human_referral_000090.jsp&mid=WC0b01ac05805c516f Accessed 23 April 2013.
  • 3
    Rossi M, Giorgi G. Domperidone and long QT syndrome. Curr Drug Saf. 2010; 5(3):257262.
  • 4
    US Food and Drug Administration. ICH guidance for industry: S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. October 2005. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074963.pdf. Accessed 31 July 2013.
  • 5
    Johannes CB, Varas-Lorenzo C, McQuay LJ, Midkiff KD, Fife D. Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study. Pharmacoepidemiol Drug Saf. 2010; 19(9):881888.
  • 6
    Van Noord C, Dieleman JP, van Herpen G, Verhamme K, Sturkenboom MCJM. Domperidone and ventricular arrhythmia or sudden cardiac death: a population-based case-control study in the Netherlands. Drug Saf. 2010; 33(11):10031014.
  • 7
    European Medicines Agency. Monthly report from the EU Pharmacovigilance Working Party, PhVWP – October 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/10/WC500117061.pdf Accessed 23 April 2013.
  • 8
    US Food and Drug Administration. ICH guidance for industry: E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. May 2005. Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf Accessed 31 July 2013.
  • 9
    US Food and Drug Administration. Guidance for Industry, Bioanalytical Methods Validation. 2001. Available at: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf Accessed 21 January 2014.
  • 10
    Viswanathan CT, Bansal S, Booth B, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res. 2007; 24(10):19621973.
  • 11
    Zhang J. Testing for positive control activity in a thorough QTc study. J Biopharm Stat. 2008; 18(3):517528.
  • 12
    Meuldermans W, Hurkmans R, Swysen E, et al. On the pharmacokinetics of domperidone in animals and man III. Comparative study on the excretion and metabolism of domperidone in rats, dogs and man. Eur J Drug Metab Pharmacokinet. 1981; 6(1):4960.
  • 13
    Lawrence CL, Bridgland-Taylor MH, Pollard CE, Hammond TG, Valentin JP. A rabbit Langendorff heart proarrhythmia model: predictive value for clinical identification of Torsades de Pointes. Br J Pharmacol. 2006; 149(7):845860.
  • 14
    Hondeghem LM. Low safety index of domperidone: mechanism for increased odds ratio for sudden cardiac death. Acta Cardiol. 2011; 66(4):421425.
  • 15
    Hondeghem LM. Domperidone: limited benefits with significant risk for sudden cardiac death. J Cardiovasc Pharmacol. 2013; 61(3):218225.