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Meeting Highlights

Cardiovascular system assessment best practices: a Safety Pharmacology Society meeting

11 – 12 May 2010, Cambridge, MA, USA

, PhD
Pages 855-866 | Published online: 08 Aug 2010

Bibliography

  • ICH Harmonised Tripartite Guideline. Safety pharmacology studies for human pharmaceuticals S7A. 2000. Available from: www.ich.org/LOB/media/MEDIA504.pdf
  • ICH Harmonised Tripartite Guideline. The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. S7B. 2005. Available from: www.ich.org/LOB/media/MEDIA2192.pdf
  • Available from: www.redbio.org/portal/encuentros/enc_2001/conferencias/C-23%20Pendiente%20en%20conferencias/C-23.pdf
  • Paul L, Hastie CE, Li WS, Resting heart rate pattern during follow-up and mortality in hypertensive patients. Hypertension 2010;55:567-74
  • Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ 1995;311(7003):485
  • Sivarajah A, Collins S, Sutton M, Cardiovascular safety assessments in the conscious telemetered dog: utilisation of super-intervals to enhance statistical power. J Pharmacol Toxicol Methods 2010; In press
  • Cavero I. Exploratory safety pharmacology: a new safety paradigm to de-risk drug candidates prior to selection for regulatory science investigations. Expert Opin Drug Saf 2009;8:627-47
  • Redfern WS, Carlsson L, Davis AS, Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovasc Res 2003;58:32-45
  • Webster R, Leishman D, Walker D. Towards a drug concentration effect relationship for QT prolongation and torsades de pointes. Curr Opin Drug Discov Dev 2002;5:116-26
  • Wallis RM. Integrated risk assessment and predictive value to humans of non-clinical repolarization assays. Br J Pharmacol 2010;159:115-21
  • Harmer A, Pollard CE, Valentin J-P. Cardiovascular system assessment: best practices [personal communication]. A Safety Pharmacology Society Meeting 11 – 12 May 2010; Cambridge, MA, USA
  • Lawrence CL, Bridgland-Taylor MH, Pollard CE, A rabbit Langendorff heart proarrhythmia model: predictive value for clinical identification of Torsades de Pointes. Br J Pharmacol 2006;149:845-60
  • Toyoshima S, Kanno A, Kitayama T, PRODACT: in vivo QT assay in the conscious dog for assessing the potential for QT interval prolongation by human pharmaceuticals. J Pharmacol Sci 2005;99:459-71
  • Hanson LA, Bass AS, Gintant G, ILSI-HESI cardiovascular safety subcommittee initiative: evaluation of three non-clinical models of QT prolongation. J Pharmacol Toxicol Methods 2006;54:116-29
  • Klon AE. Machine learning algorithms for the prediction of hERG and CYP450 binding in drug development. Expert Opin Drug Metab Toxicol 2010;6:821-33
  • Valentin JP, Bialecki R, Ewart L, A framework to assess the translation of safety pharmacology data to humans. J Pharmacol Toxicol Methods 2009;60:152-8
  • Trepakova ES, Koerner J, Pettit SD, HESI Pro-Arrhythmia Committee. A HESI consortium approach to assess the human predictive value of non-clinical repolarization assays. J Pharmacol Toxicol Methods 2009;60:45-50
  • Lasser KE, Allen PD, Woolhandler SJ, Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287:2215-20
  • Piccini JP, Whellan DJ, Berridge BR, Current challenges in the evaluation of cardiac safety during drug development: translational medicine meets the Critical Path Initiative. Am Heart J 2009;158:317-26
  • Holzgrefe HH, Cavero I, Gleason CR, Novel probabilistic method for precisely correcting the QT interval for heart rate in telemetered dogs and cynomolgus monkeys. J Pharmacol Toxicol Methods 2007;55:159-75
  • Holzgrefe HH, Cavero I, Buchanan LV, Application of a probabilistic method for the determination of drug-induced QT prolongation in telemetered cynomolgus monkeys: effects of moxifloxacin. J Pharmacol Toxicol Methods 2007;55:227-37
  • Champeroux P, Martel E, Fowler JS, Calculation of QT shift in non clinical safety pharmacology studies. J Pharmacol Toxicol Methods 2009;59:73-85
  • Van Der Linde HJ, Van Deuren B, Teisman A, The effect of changes in core body temperature on the QT interval in beagle dogs: a previously ignored phenomenon, with a method for correction. Br J Pharmacol 2008;154:1474-81
  • Cavero I. Safety Pharmacology Society: 9th Annual Meeting. Expert Opin Drug Saf 2010;9:365-78
  • ICH Harmonised Tripartite Guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs E14. Available from: www.ich.org/LOB/media/MEDIA1476.pdf
  • Stevens JL, Baker TK. The future of drug safety testing: expanding the view and narrowing the focus. Drug Discov Today 2009;14:162-7
  • Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 2009;8:959-68
  • Paul SM, Mytelka DS, Dunwiddie CT, How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov 2010;9:203-14
  • Matthews EJ, Frid AA. Prediction of drug-related cardiac adverse effects in humans-A: creation of a database of effects and identification of factors affecting their occurrence. Regul Toxicol Pharmacol 2010;56:247-75
  • Frid AA, Matthews EJ. Prediction of drug-related cardiac adverse effects in humans-B: use of QSAR programs for early detection of drug-induced cardiac toxicities. Regul Toxicol Pharmacol 2010;56:276-89
  • Kirk B, Arvidson KB, Ronald Chanderbhan R, Regulatory use of computational toxicology tools and databases at the United States Food and Drug Administration's Office of Food Additive Safety. Expert Opin Drug Metab Toxicol 2010;6:821-33
  • Pettit SD, Berridge B, Sarazan RD. A call for more integrated cardiovascular safety assessment. J Pharmacol Toxicol Methods 2010;61:1-2

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