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Volumn 19, Issue 3, 2014, Pages 275-281

In vitro-in vivo extrapolation of drug-induced proarrhythmia predictions at the population level

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE DRUG REACTION; DRUG INDUSTRY; DRUG SAFETY; HEART PROARRHYTHMIA; HUMAN; IN VITRO IN VIVO EXTRAPOLATION; MATHEMATICAL MODEL; POPULATION RESEARCH; PREDICTION; REVIEW; ANIMAL; CARDIOTOXICITY; CHEMICALLY INDUCED; COST BENEFIT ANALYSIS; ECONOMICS; HEART ARRHYTHMIA; PATHOPHYSIOLOGY; PROCEDURES; THEORETICAL MODEL; TOXICITY TESTING; TRANSLATIONAL RESEARCH;

EID: 84896405843     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2013.10.009     Document Type: Review
Times cited : (23)

References (66)
  • 1
    • 79959542097 scopus 로고    scopus 로고
    • Adverse drug reactions in Germany: Direct costs of internal medicine hospitalizations
    • D. Rottenkolber et al. Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations Pharmacoepidemiol. Drug. Saf. 20 2011 626 634
    • (2011) Pharmacoepidemiol. Drug. Saf. , vol.20 , pp. 626-634
    • Rottenkolber, D.1
  • 2
    • 84861305959 scopus 로고    scopus 로고
    • Adverse drug reactions in hospital in-patients: A prospective analysis of 3695 patient-episodes
    • E.C. Davies et al. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes PLoS One 4 2009 1 7
    • (2009) PLoS One , vol.4 , pp. 1-7
    • Davies, E.C.1
  • 3
    • 33749448371 scopus 로고    scopus 로고
    • Torsade de pointes induced by systemic antifungal agents: Lessons from a retrospective analysis of published case reports
    • DOI 10.1111/j.1439-0507.2006.01278.x
    • D. Justo, and D. Zeltser Torsade de pointes induced by systemic antifungal agents: lessons from a retrospective analysis of published case reports Mycoses 49 2006 463 470 (Pubitemid 44511096)
    • (2006) Mycoses , vol.49 , Issue.6 , pp. 463-470
    • Justo, D.1    Zeltser, D.2
  • 4
    • 77149155968 scopus 로고    scopus 로고
    • Trends in risks associated with new drug development: Success rates for investigational drugs
    • J.A. DiMasi et al. Trends in risks associated with new drug development: success rates for investigational drugs Clin. Pharmacol. Ther. 87 2010 272 277
    • (2010) Clin. Pharmacol. Ther. , vol.87 , pp. 272-277
    • Dimasi, J.A.1
  • 5
    • 79958067466 scopus 로고    scopus 로고
    • Impact and frequency of different toxicities throughout the pharmaceutical life cycle
    • W.S. Redfern et al. Impact and frequency of different toxicities throughout the pharmaceutical life cycle Toxicologist 114 2010 1081
    • (2010) Toxicologist , vol.114 , pp. 1081
    • Redfern, W.S.1
  • 6
    • 68949149740 scopus 로고    scopus 로고
    • Current challenges in the evaluation of cardiac safety during drug development: Translational medicine meets the Critical Path Initiative
    • J.P. Piccini et al. Current challenges in the evaluation of cardiac safety during drug development: translational medicine meets the Critical Path Initiative Am. Heart. J. 158 2009 317 326
    • (2009) Am. Heart. J. , vol.158 , pp. 317-326
    • Piccini, J.P.1
  • 7
    • 58849132807 scopus 로고    scopus 로고
    • The future of drug safety testing: Expanding the view and narrowing the focus
    • J.L. Stevens, and T.K. Baker The future of drug safety testing: expanding the view and narrowing the focus Drug Discov. Today 14 2009 162 167
    • (2009) Drug Discov. Today , vol.14 , pp. 162-167
    • Stevens, J.L.1    Baker, T.K.2
  • 8
    • 85056037703 scopus 로고    scopus 로고
    • A comparison of the performance and application differences between manual and automated patch-clamp techniques
    • X. Yajuan et al. A comparison of the performance and application differences between manual and automated patch-clamp techniques Curr. Chem. Genomics 6 2012 87 92
    • (2012) Curr. Chem. Genomics , vol.6 , pp. 87-92
    • Yajuan, X.1
  • 9
    • 68549109498 scopus 로고    scopus 로고
    • Blockade of the I(Ks) potassium channel: An overlooked cardiovascular liability in drug safety screening?
    • R. Towart et al. Blockade of the I(Ks) potassium channel: an overlooked cardiovascular liability in drug safety screening? J. Pharmacol. Toxicol. Methods 60 2009 1 10
    • (2009) J. Pharmacol. Toxicol. Methods , vol.60 , pp. 1-10
    • Towart, R.1
  • 10
    • 64749109727 scopus 로고    scopus 로고
    • A meta-analysis of cardiac electrophysiology computational models
    • S.A. Niederer et al. A meta-analysis of cardiac electrophysiology computational models Exp. Physiol. 94 2009 486 495
    • (2009) Exp. Physiol. , vol.94 , pp. 486-495
    • Niederer, S.A.1
  • 11
    • 64749093367 scopus 로고    scopus 로고
    • Towards predictive modelling of the electrophysiology of the heart
    • E. Vigmond et al. Towards predictive modelling of the electrophysiology of the heart Exp. Physiol. 94 2009 563 577
    • (2009) Exp. Physiol. , vol.94 , pp. 563-577
    • Vigmond, E.1
  • 14
    • 33644524405 scopus 로고    scopus 로고
    • Are hERG channel inhibition and QT interval prolongation all there is in drug induced torsadogenesis? A review of emerging trends
    • P. Hoffmann, and B. Warner Are hERG channel inhibition and QT interval prolongation all there is in drug induced torsadogenesis? A review of emerging trends J. Pharmacol. Toxicol. Methods 53 2006 87 105
    • (2006) J. Pharmacol. Toxicol. Methods , vol.53 , pp. 87-105
    • Hoffmann, P.1    Warner, B.2
  • 15
    • 79955419099 scopus 로고    scopus 로고
    • Simulation of multiple ion channel block provides improved early prediction of compounds' clinical torsadogenic risk
    • G.R. Mirams et al. Simulation of multiple ion channel block provides improved early prediction of compounds' clinical torsadogenic risk Cardiovasc. Res. 91 2011 53 61
    • (2011) Cardiovasc. Res. , vol.91 , pp. 53-61
    • Mirams, G.R.1
  • 20
    • 84880116735 scopus 로고    scopus 로고
    • MICE models: Superior to the HERG model in predicting Torsade de pointes
    • 10.1038/srep02100
    • J. Kramer et al. MICE models: superior to the HERG model in predicting Torsade de pointes Scientific Reports 3 2013 2100 10.1038/srep02100
    • (2013) Scientific Reports , vol.3 , pp. 2100
    • Kramer, J.1
  • 21
    • 33947587274 scopus 로고    scopus 로고
    • Simulation and prediction of in vivo drug metabolism in human populations from in vitro data
    • DOI 10.1038/nrd2173, PII NRD2173
    • A. Rostami-Hodjegan, and G.T. Tucker Simulation and prediction of in vivo drug metabolism in human populations from in vitro data Nat. Rev. Drug Discov. 6 2007 140 148 (Pubitemid 46745341)
    • (2007) Nature Reviews Drug Discovery , vol.6 , Issue.2 , pp. 140-148
    • Rostami-Hodjegan, A.1    Tucker, G.T.2
  • 22
    • 0037083795 scopus 로고    scopus 로고
    • Sex, hormones, and repolarization
    • DOI 10.1016/S0008-6363(01)00429-1, PII S0008636301004291
    • T.V. Pham., and M.R. Rosen Sex, hormones, and repolarization Cardiovasc. Res. 53 2002 740 751 (Pubitemid 34175265)
    • (2002) Cardiovascular Research , vol.53 , Issue.3 , pp. 740-751
    • Pham, T.V.1    Rosen, M.R.2
  • 23
    • 84865747122 scopus 로고    scopus 로고
    • Sex hormones and the QT interval: A review
    • T. Sedlak et al. Sex hormones and the QT interval: a review J. Womens Health 21 2012 933 941
    • (2012) J. Womens Health , vol.21 , pp. 933-941
    • Sedlak, T.1
  • 25
    • 63449140005 scopus 로고    scopus 로고
    • Clinical characteristics of patients with drug-induced QT interval prolongation and torsade de pointes: Identification of risk factors
    • K.P. Letsas et al. Clinical characteristics of patients with drug-induced QT interval prolongation and torsade de pointes: identification of risk factors Clin. Res. Cardiol. 98 2009 208 212
    • (2009) Clin. Res. Cardiol. , vol.98 , pp. 208-212
    • Letsas, K.P.1
  • 26
    • 84856995147 scopus 로고    scopus 로고
    • Pharmacokinetic interaction between domperidone and ketoconazole leads to QT prolongation in healthy volunteers: A randomized, placebo-controlled, double-blind, crossover study
    • M.J. Boyce et al. Pharmacokinetic interaction between domperidone and ketoconazole leads to QT prolongation in healthy volunteers: a randomized, placebo-controlled, double-blind, crossover study Br. J. Clin. Pharmacol. 73 2012 411 421
    • (2012) Br. J. Clin. Pharmacol. , vol.73 , pp. 411-421
    • Boyce, M.J.1
  • 27
    • 0029031870 scopus 로고
    • Diurnal oscillations in the serum and salivary levels of quinidine
    • B.R. Rao, and D. Rambhau Diurnal oscillations in the serum and salivary levels of quinidine Arzneimittelforschung. 45 1995 681 683
    • (1995) Arzneimittelforschung. , vol.45 , pp. 681-683
    • Rao, B.R.1    Rambhau, D.2
  • 28
    • 0022633531 scopus 로고
    • Temporal variation in triazolam pharmacokinetics and pharmacodynamics after oral administration
    • R.B. Smith et al. Temporal variation in triazolam pharmacokinetics and pharmacodynamics after oral administration J. Clin. Pharmacol. 26 1986 120 124 (Pubitemid 16134437)
    • (1986) Journal of Clinical Pharmacology , vol.26 , Issue.2 , pp. 120-124
    • Smith, R.B.1    Kroboth, P.D.2    Phillips, J.P.3
  • 30
    • 84896397101 scopus 로고    scopus 로고
    • Chronobiological aspects of ketamine/xylazine anesthesia impact on the cardiovascular system, the acid-base balance, ions and autonomic nervous system in Wistar rats
    • Abstr. P91
    • P. Svorc et al. Chronobiological aspects of ketamine/xylazine anesthesia impact on the cardiovascular system, the acid-base balance, ions and autonomic nervous system in Wistar rats Acta Physiol. 206 Suppl. 693 2012 Abstr. P91
    • (2012) Acta Physiol. , vol.206 , Issue.SUPPL. 693
    • Svorc, P.1
  • 31
    • 0026345910 scopus 로고
    • Chronopharmacokinetics and cardiovascular effects of nifedipine
    • B. Lemmer et al. Chronopharmacokinetics and cardiovascular effects of nifedipine Chronobiol. Int. 8 1991 485 494
    • (1991) Chronobiol. Int. , vol.8 , pp. 485-494
    • Lemmer, B.1
  • 32
    • 84855895068 scopus 로고    scopus 로고
    • Adherence to medications: Insights arising from studies on the unreliable link between prescribed and actual drug dosing histories
    • T.F. Blaschke et al. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories Annu. Rev. Pharmacol. Toxicol. 52 2012 275 301
    • (2012) Annu. Rev. Pharmacol. Toxicol. , vol.52 , pp. 275-301
    • Blaschke, T.F.1
  • 34
    • 80053978150 scopus 로고    scopus 로고
    • Adherence to immunosuppression in adult lung transplant recipients: Prevalence and risk factors
    • O.H. Bosma et al. Adherence to immunosuppression in adult lung transplant recipients: prevalence and risk factors J. Heart Lung Transplant 30 2011 1275 1280
    • (2011) J. Heart Lung Transplant , vol.30 , pp. 1275-1280
    • Bosma, O.H.1
  • 35
    • 3042645546 scopus 로고    scopus 로고
    • Phase IV trial evaluating the effectiveness and safety of dofetilide
    • DOI 10.1345/aph.1D465
    • A.V. Guanzon, and M.A. Crouch Phase IV trial evaluating the effectiveness and safety of dofetilide Ann. Pharmacother. 38 2004 1142 1147 (Pubitemid 38802149)
    • (2004) Annals of Pharmacotherapy , vol.38 , Issue.7-8 , pp. 1142-1147
    • Guanzon, A.V.1    Crouch, M.A.2
  • 36
    • 48249088061 scopus 로고    scopus 로고
    • Medication persistence rates and factors associated with persistence in patients following stroke: A cohort study
    • H.L. Lummis et al. Medication persistence rates and factors associated with persistence in patients following stroke: a cohort study BMC Neurol. 8 2008 25
    • (2008) BMC Neurol. , vol.8 , pp. 25
    • Lummis, H.L.1
  • 37
    • 84862619047 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: A marriage under the arch of systems pharmacology
    • A. Rostami-Hodjegan Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: a marriage under the arch of systems pharmacology Clin. Pharmacol. Ther. 92 2012 50 61
    • (2012) Clin. Pharmacol. Ther. , vol.92 , pp. 50-61
    • Rostami-Hodjegan, A.1
  • 38
    • 35649016144 scopus 로고    scopus 로고
    • Modelling and simulation in prediction of human xenobiotic absorption, distribution, metabolism and excretion (ADME): In vitro-in vivo extrapolations (IVIVE)
    • G.G. Gibson, and A. Rostami-Hodjegan Modelling and simulation in prediction of human xenobiotic absorption, distribution, metabolism and excretion (ADME): in vitro-in vivo extrapolations (IVIVE) Xenobiotica 37 2007 1013 1014
    • (2007) Xenobiotica , vol.37 , pp. 1013-1014
    • Gibson, G.G.1    Rostami-Hodjegan, A.2
  • 39
    • 84874849830 scopus 로고    scopus 로고
    • Predicting drug-drug interactions: Application of physiologically based pharmacokinetic models under a systems biology approach
    • K.R. Yeo et al. Predicting drug-drug interactions: application of physiologically based pharmacokinetic models under a systems biology approach Expert Rev. Clin. Pharmacol. 6 2013 143 157
    • (2013) Expert Rev. Clin. Pharmacol. , vol.6 , pp. 143-157
    • Yeo, K.R.1
  • 41
    • 77249090840 scopus 로고    scopus 로고
    • A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance
    • T.N. Johnson et al. A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance Clin. Pharmacokinet. 49 2010 189 206
    • (2010) Clin. Pharmacokinet. , vol.49 , pp. 189-206
    • Johnson, T.N.1
  • 42
    • 79952747590 scopus 로고    scopus 로고
    • Modeling and predicting drug pharmacokinetics in patients with renal impairment
    • K.R. Yeo et al. Modeling and predicting drug pharmacokinetics in patients with renal impairment Expert Rev. Clin. Pharmacol. 4 2011 261 274
    • (2011) Expert Rev. Clin. Pharmacol. , vol.4 , pp. 261-274
    • Yeo, K.R.1
  • 43
    • 84883867728 scopus 로고    scopus 로고
    • In vitro to human in vivo translation-pharmacokinetics and pharmacodynamics of quinidine
    • S. Polak In vitro to human in vivo translation-pharmacokinetics and pharmacodynamics of quinidine ALTEX 30 2013 309 318
    • (2013) ALTEX , vol.30 , pp. 309-318
    • Polak, S.1
  • 44
    • 84867283408 scopus 로고    scopus 로고
    • Application of cardiac electrophysiology simulations to pro-arrhythmic safety testing
    • G.R. Mirams et al. Application of cardiac electrophysiology simulations to pro-arrhythmic safety testing Br. J. Pharmacol. 167 2012 932 945
    • (2012) Br. J. Pharmacol. , vol.167 , pp. 932-945
    • Mirams, G.R.1
  • 45
    • 80052358982 scopus 로고    scopus 로고
    • A computational model to predict the effects of class i anti-arrhythmic drugs on ventricular rhythms
    • J.D. Moreno et al. A computational model to predict the effects of class I anti-arrhythmic drugs on ventricular rhythms Sci. Transl. Med. 3 2011 98ra83
    • (2011) Sci. Transl. Med. , vol.3
    • Moreno, J.D.1
  • 46
    • 84872373202 scopus 로고    scopus 로고
    • Computational assessment of drug-induced effects on the electrocardiogram: From ion channel to body surface potentials
    • N. Zemzemi et al. Computational assessment of drug-induced effects on the electrocardiogram: from ion channel to body surface potentials Br. J. Pharmacol. 168 2013 718 733
    • (2013) Br. J. Pharmacol. , vol.168 , pp. 718-733
    • Zemzemi, N.1
  • 47
    • 84879786587 scopus 로고    scopus 로고
    • Modeling gender effects on electrical activity of single ventricular myocytes
    • J. Cieniawa et al. Modeling gender effects on electrical activity of single ventricular myocytes Comput. Biol. Med. 43 2013 1063 1072
    • (2013) Comput. Biol. Med. , vol.43 , pp. 1063-1072
    • Cieniawa, J.1
  • 48
    • 83455253531 scopus 로고    scopus 로고
    • Virtual population generator for human cardiomyocytes parameters. in silico drug cardiotoxicity assessment
    • S. Polak et al. Virtual population generator for human cardiomyocytes parameters. In silico drug cardiotoxicity assessment Toxicol. Mech. Methods 22 2012 31 40
    • (2012) Toxicol. Mech. Methods , vol.22 , pp. 31-40
    • Polak, S.1
  • 49
    • 84865842390 scopus 로고    scopus 로고
    • Inter-individual variability in the pre-clinical drug cardiotoxic safety assessment - Analysis of the age - Cardiomyocytes electric capacitance dependence
    • S. Polak, and K. Fijorek Inter-individual variability in the pre-clinical drug cardiotoxic safety assessment - analysis of the age - cardiomyocytes electric capacitance dependence J. Cardiovasc. Transl. Res. 5 2012 321 332
    • (2012) J. Cardiovasc. Transl. Res. , vol.5 , pp. 321-332
    • Polak, S.1    Fijorek, K.2
  • 50
    • 84873437083 scopus 로고    scopus 로고
    • Age and gender dependent heart rate circadian model development and performance verification on the proarrhythmic drug case study
    • K. Fijorek et al. Age and gender dependent heart rate circadian model development and performance verification on the proarrhythmic drug case study Theor. Biol. Med. Model. 10 2013 7
    • (2013) Theor. Biol. Med. Model. , vol.10 , pp. 7
    • Fijorek, K.1
  • 51
    • 84872773062 scopus 로고    scopus 로고
    • Gender differences in electrophysiological gene expression in failing and non-failing human hearts
    • C.M. Ambrosi et al. Gender differences in electrophysiological gene expression in failing and non-failing human hearts PLoS One 8 2013 e54635
    • (2013) PLoS One , vol.8 , pp. 54635
    • Ambrosi, C.M.1
  • 52
    • 84874236004 scopus 로고    scopus 로고
    • MRNA expression levels in failing human hearts predict cellular electrophysiological remodeling: A population based simulation study
    • J. Walmsley et al. mRNA expression levels in failing human hearts predict cellular electrophysiological remodeling: a population based simulation study PLoS One 8 2013 e56359
    • (2013) PLoS One , vol.8 , pp. 56359
    • Walmsley, J.1
  • 53
    • 84878734095 scopus 로고    scopus 로고
    • Experimentally calibrated population of models predicts and explains intersubject variability in cardiac cellular electrophysiology
    • 10.1073/pnas.1304382110
    • O.J. Britton et al. Experimentally calibrated population of models predicts and explains intersubject variability in cardiac cellular electrophysiology PNAS 2013 10.1073/pnas.1304382110
    • (2013) PNAS
    • Britton, O.J.1
  • 54
    • 84876572513 scopus 로고    scopus 로고
    • Dealing with global safety issues: Was the response to QT-liability of non-cardiac drugs well coordinated?
    • N. Stockbridge et al. Dealing with global safety issues: was the response to QT-liability of non-cardiac drugs well coordinated? Drug Saf. 36 2013 167 182
    • (2013) Drug Saf. , vol.36 , pp. 167-182
    • Stockbridge, N.1
  • 55
    • 84881283663 scopus 로고    scopus 로고
    • Revolution dawning in cardiotoxicity testing
    • K.R. Chi Revolution dawning in cardiotoxicity testing Nat. Rev. Drug Discov. 12 2013 565 567
    • (2013) Nat. Rev. Drug Discov. , vol.12 , pp. 565-567
    • Chi, K.R.1
  • 56
    • 84875768136 scopus 로고    scopus 로고
    • Patient-specific modeling of the heart: Estimation of ventricular fiber orientations
    • 10.3791/50125
    • F. Vadakkumpadan et al. Patient-specific modeling of the heart: estimation of ventricular fiber orientations J. Vis. Exp. 2013 50125 10.3791/50125
    • (2013) J. Vis. Exp. , pp. 50125
    • Vadakkumpadan, F.1
  • 57
    • 34248656992 scopus 로고    scopus 로고
    • Recent advances in understanding sex differences in cardiac repolarization
    • DOI 10.1016/j.pbiomolbio.2005.05.010, PII S0079610705000350
    • A.F. James et al. Recent advances in understanding sex differences in cardiac repolarization Prog. Biophys. Mol. Biol. 94 2007 265 319 (Pubitemid 46766581)
    • (2007) Progress in Biophysics and Molecular Biology , vol.94 , Issue.3 , pp. 265-319
    • James, A.F.1    Choisy, S.C.M.2    Hancox, J.C.3
  • 58
  • 60
    • 0038641346 scopus 로고    scopus 로고
    • Structural pathways and prevention of heart failure and sudden death
    • A. Pacifico, and P.D. Henry Structural pathways and prevention of heart failure and sudden death J. Cardiovasc. Electrophysiol. 14 2003 764 775 (Pubitemid 36849617)
    • (2003) Journal of Cardiovascular Electrophysiology , vol.14 , Issue.7 , pp. 764-775
    • Pacifico, A.1    Henry, P.D.2
  • 62
    • 77950891253 scopus 로고    scopus 로고
    • M cells in the human heart
    • C. Antzelevitch M cells in the human heart Circ. Res. 106 2010 815 817
    • (2010) Circ. Res. , vol.106 , pp. 815-817
    • Antzelevitch, C.1
  • 63
    • 84896396123 scopus 로고    scopus 로고
    • A meta-analysis of ECG data from healthy male volunteers: Diurnal and intra-subject variability, and implications for planning ECG assessments and statistical analysis in clinical pharmacology studies
    • R.I. Harris, and S.E. Steare A meta-analysis of ECG data from healthy male volunteers: diurnal and intra-subject variability, and implications for planning ECG assessments and statistical analysis in clinical pharmacology studies Heart 89 2003 882 886
    • (2003) Heart , vol.89 , pp. 882-886
    • Harris, R.I.1    Steare, S.E.2
  • 64
    • 0036181222 scopus 로고    scopus 로고
    • Relation between QT and RR intervals is highly individual among healthy subjects: Implications for heart rate correction of the QT interval
    • M. Malik et al. Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval Heart 87 2002 220 228 (Pubitemid 34177674)
    • (2002) Heart , vol.87 , Issue.3 , pp. 220-228
    • Malik, M.1    Farbom, P.2    Batchvarov, V.3    Hnatkova, K.4    Camm, A.J.5


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