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Volumn 95, Issue 5, 2014, Pages 501-508

Improving the assessment of heart toxicity for all new drugs through translational regulatory science

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM CHANNEL; CALCIUM CHANNEL BLOCKING AGENT; NEW DRUG; PLACEBO; POTASSIUM CHANNEL; POTASSIUM CHANNEL HERG; SODIUM CHANNEL BLOCKING AGENT;

EID: 84899409128     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.238     Document Type: Article
Times cited : (84)

References (41)
  • 1
    • 79952055751 scopus 로고    scopus 로고
    • Advancing regulatory science
    • Hamburg, M.A. Advancing regulatory science. Science 331, 987 (2011).
    • (2011) Science , vol.331 , pp. 987
    • Hamburg, M.A.1
  • 2
    • 84899461324 scopus 로고    scopus 로고
    • Availability of masked and de-identifed non-summary safety and efcacy data; Request for comments
    • Availability of masked and de-identifed non-summary safety and efcacy data; request for comments. Fed. Reg. 78, 33421-33423 (2013).
    • (2013) Fed. Reg. , vol.78 , pp. 33421-33423
  • 3
    • 0013881809 scopus 로고
    • [Ventricular tachycardia with 2 variable opposing foci]
    • Dessertenne, F. [Ventricular tachycardia with 2 variable opposing foci]. Arch. Mal. Coeur Vaiss. 59, 263-272 (1966).
    • (1966) Arch. Mal. Coeur Vaiss. , vol.59 , pp. 263-272
    • Dessertenne, F.1
  • 7
    • 84876572513 scopus 로고    scopus 로고
    • Dealing with global safety issues: Was the response to QT-liability of non-cardiac drugs well coordinated?
    • Stockbridge, N., Morganroth, J., Shah, R.R. & Garnett, C. Dealing with global safety issues: was the response to QT-liability of non-cardiac drugs well coordinated? Drug Saf. 36, 167-182 (2013).
    • (2013) Drug Saf. , vol.36 , pp. 167-182
    • Stockbridge, N.1    Morganroth, J.2    Shah, R.R.3    Garnett, C.4
  • 8
    • 72049116795 scopus 로고    scopus 로고
    • Thorough QT Studies: Questions and Quandaries
    • Malik, M., Garnett, C.E. & Zhang, J. Thorough QT Studies: Questions and Quandaries. Drug Saf. 33, 1-14 (2010).
    • (2010) Drug Saf. , vol.33 , pp. 1-14
    • Malik, M.1    Garnett, C.E.2    Zhang, J.3
  • 9
    • 0029007356 scopus 로고
    • HERG, a human inward rectifer in the voltage-gated potassium channel family
    • Trudeau, M.C., Warmke, J.W., Ganetzky, B. & Robertson, G.A. HERG, a human inward rectifer in the voltage-gated potassium channel family. Science 269, 92-95 (1995).
    • (1995) Science , vol.269 , pp. 92-95
    • Trudeau, M.C.1    Warmke, J.W.2    Ganetzky, B.3    Robertson, G.A.4
  • 10
    • 0032831711 scopus 로고    scopus 로고
    • Spatial, temporal and wavefront direction characteristics of 12-lead T-wave morphology
    • Acar, B., yi, G., Hnatkova, K. & Malik, M. Spatial, temporal and wavefront direction characteristics of 12-lead T-wave morphology. Med. Biol. Eng. Comput. 37, 574-584 (1999). (Pubitemid 29488393)
    • (1999) Medical and Biological Engineering and Computing , vol.37 , Issue.5 , pp. 574-584
    • Acar, B.1    Yi, G.2    Hnatkova, K.3    Malik, M.4
  • 11
    • 79959935358 scopus 로고    scopus 로고
    • T-wave morphology abnormalities in benign, potent, and arrhythmogenic I(kr) inhibition
    • Couderc, J.P. et al. T-wave morphology abnormalities in benign, potent, and arrhythmogenic I(kr) inhibition. Heart Rhythm 8, 1036-1043 (2011).
    • (2011) Heart Rhythm , vol.8 , pp. 1036-1043
    • Couderc, J.P.1
  • 12
    • 70350432728 scopus 로고    scopus 로고
    • Quantitative analysis of T-wave morphology increases confdence in drug-induced cardiac repolarization abnormalities: Evidence from the investigational IKr inhibitor Lu 35-138
    • Graf, C. et al. Quantitative analysis of T-wave morphology increases confdence in drug-induced cardiac repolarization abnormalities: evidence from the investigational IKr inhibitor Lu 35-138. J. Clin. Pharmacol. 49, 1331-1342 (2009).
    • (2009) J. Clin. Pharmacol. , vol.49 , pp. 1331-1342
    • Graf, C.1
  • 14
    • 0033553504 scopus 로고    scopus 로고
    • Mechanism of block and identification of the verapamil binding domain to HERG potassium channels
    • Zhang, S., Zhou, Z., Gong, Q., Makielski, J.C. & January, C.T. Mechanism of block and identifcation of the verapamil binding domain to HERG potassium channels. Circ. Res. 84, 989-998 (1999). (Pubitemid 29227678)
    • (1999) Circulation Research , vol.84 , Issue.9 , pp. 989-998
    • Zhang, S.1    Zhou, Z.2    Gong, Q.3    Makielski, J.C.4    January, C.T.5
  • 16
    • 33846347308 scopus 로고    scopus 로고
    • L-type calcium current reactivation contributes to arrhythmogenesis associated with action potential triangulation
    • DOI 10.1111/j.1540-8167.2006.00698.x
    • Guo, D., Zhao, X., Wu, Y., Liu, T., Kowey, P.R. & yan, G.X. L-type calcium current reactivation contributes to arrhythmogenesis associated with action potential triangulation. J. Cardiovasc. Electrophysiol. 18, 196-203 (2007). (Pubitemid 46130770)
    • (2007) Journal of Cardiovascular Electrophysiology , vol.18 , Issue.2 , pp. 196-203
    • Guo, D.1    Zhao, X.2    Wu, Y.3    Liu, T.4    Kowey, P.R.5    Yan, G.-X.6
  • 17
    • 0024556795 scopus 로고
    • 2+ current
    • January, C.T. & Riddle, J.M. Early afterdepolarizations: mechanism of induction and block. A role for L-type Ca2+ current. Circ. Res. 64, 977-990 (1989). (Pubitemid 19117651)
    • (1989) Circulation Research , vol.64 , Issue.5 , pp. 977-990
    • January, C.T.1    Riddle, J.M.2
  • 21
    • 84866315200 scopus 로고    scopus 로고
    • Automatic ECG quality scoring methodology: Mimicking human annotators
    • Johannesen, L. & Galeotti, L Automatic ECG quality scoring methodology: mimicking human annotators. Physiol. Meas. 33, 1479-1489 (2012).
    • (2012) Physiol. Meas. , vol.33 , pp. 1479-1489
    • Johannesen, L.1    Galeotti, L.2
  • 23
    • 84870845910 scopus 로고    scopus 로고
    • Transformation of the Mason-Likar 12-lead electrocardiogram to the Frank vectorcardiogram
    • Guldenring, D. et al. Transformation of the Mason-Likar 12-lead electrocardiogram to the Frank vectorcardiogram. Conf. Proc. IEEE Eng. Med Biol. Soc. 2012, 677-680 (2012).
    • (2012) Conf. Proc. IEEE Eng. Med Biol. Soc. , vol.2012 , pp. 677-680
    • Guldenring, D.1
  • 24
    • 84980096143 scopus 로고
    • Die Systolendauer im Elektrokardiogramm bei normalen Menschen und bei Herzkranken.
    • Fridericia, LS. Die Systolendauer im Elektrokardiogramm bei normalen Menschen und bei Herzkranken. Acta Medica Scandinavica 54, 17-50 (1920).
    • (1920) Acta Medica Scandinavica , vol.54 , pp. 17-50
    • Fridericia, L.S.1
  • 25
    • 80054978661 scopus 로고    scopus 로고
    • Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability
    • Malik, M., Zhang, J., Johannesen, L., Hnatkova, K. & Garnett, C. Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability. Heart Rhythm 8, 1777-1785 (2011).
    • (2011) Heart Rhythm , vol.8 , pp. 1777-1785
    • Malik, M.1    Zhang, J.2    Johannesen, L.3    Hnatkova, K.4    Garnett, C.5
  • 26
    • 79151474418 scopus 로고    scopus 로고
    • An evaluation of hERG current assay performance: Translating preclinical safety studies to clinical QT prolongation
    • Gintant, G. An evaluation of hERG current assay performance: translating preclinical safety studies to clinical QT prolongation. Pharmacol. Ther. 129, 109-119 (2011).
    • (2011) Pharmacol. Ther. , vol.129 , pp. 109-119
    • Gintant, G.1
  • 27
    • 0017128333 scopus 로고
    • Efects of atrio-ventricular conduction of calcium-antagonistic coronary vasodilators, local anaesthetics and quinidine injected into the posterior and the anterior septal artery of the atrio-ventricular node preparation of the dog
    • Narimatsu, A. & Taira, N. Efects of atrio-ventricular conduction of calcium-antagonistic coronary vasodilators, local anaesthetics and quinidine injected into the posterior and the anterior septal artery of the atrio-ventricular node preparation of the dog. Naunyn Schmiedebergs Arch. Pharmacol. 294, 169-177 (1976).
    • (1976) Naunyn Schmiedebergs Arch. Pharmacol. , vol.294 , pp. 169-177
    • Narimatsu, A.1    Taira, N.2
  • 28
    • 79958158591 scopus 로고    scopus 로고
    • Simulation of the undiseased human cardiac ventricular action potential: Model formulation and experimental validation
    • O'Hara, T., Virág, L, Varró, A. & Rudy, Y. Simulation of the undiseased human cardiac ventricular action potential: model formulation and experimental validation. PLoS Comput. Biol. 7, e1002061 (2011).
    • (2011) PLoS Comput. Biol. , vol.7
    • O'Hara, T.1    Virág, L.2    Varró, A.3    Rudy, Y.4
  • 29
    • 0742307477 scopus 로고    scopus 로고
    • ECGSIM: An interactive tool for studying the genesis of QRST waveforms
    • Oosterom, A.v. & Oostendorp, T.F. ECGSIM: an interactive tool for studying the genesis of QRST waveforms. Heart 90, 165-168 (2004). (Pubitemid 38147151)
    • (2004) Heart , vol.90 , Issue.2 , pp. 165-168
    • Van Oosterom, A.1    Oostendorp, T.F.2
  • 30
    • 79955419099 scopus 로고    scopus 로고
    • Simulation of multiple ion channel block provides improved early prediction of compounds' clinical torsadogenic risk
    • Mirams, G.R. et al. Simulation of multiple ion channel block provides improved early prediction of compounds' clinical torsadogenic risk. Cardiovasc. Res. 91, 53-61 (2011).
    • (2011) Cardiovasc. Res. , vol.91 , pp. 53-61
    • Mirams, G.R.1
  • 31
    • 0035698306 scopus 로고    scopus 로고
    • Genesis of the T wave as based on an equivalent surface source model
    • DOI 10.1054/jelc.2001.28896
    • van Oosterom, A. Genesis of the T wave as based on an equivalent surface source model. J. Electrocardiol. 34(suppl.), 217-227 (2001). (Pubitemid 34083926)
    • (2001) Journal of Electrocardiology , vol.34 , Issue.SUPPL. , pp. 217-227
    • Van Oosterom, A.1
  • 33
    • 0035194585 scopus 로고    scopus 로고
    • Electrical heterogeneity within the ventricular wall
    • DOI 10.1007/s003950170002
    • Antzelevitch, C. & Fish, J. Electrical heterogeneity within the ventricular wall. Basic Res. Cardiol. 96, 517-527 (2001). (Pubitemid 33121024)
    • (2001) Basic Research in Cardiology , vol.96 , Issue.6 , pp. 517-527
    • Antzelevitch, C.1    Fish, J.2
  • 34
    • 0014708347 scopus 로고
    • Efect of lidocaine on the electrophysiological properties of ventricular muscle and purkinje fbers
    • Bigger, J.T. Jr & Mandel, W.J. Efect of lidocaine on the electrophysiological properties of ventricular muscle and purkinje fbers. J. Clin. Invest. 49, 63-77 (1970).
    • (1970) J. Clin. Invest. , vol.49 , pp. 63-77
    • Bigger, Jr.J.T.1    Mandel, W.J.2
  • 35
    • 84880116735 scopus 로고    scopus 로고
    • MICE models: Superior to the HERG model in predicting Torsade de Pointes
    • Kramer, J. et al. MICE models: superior to the HERG model in predicting Torsade de Pointes. Sci. Rep. 3, 2100 (2013).
    • (2013) Sci. Rep. , vol.3 , pp. 2100
    • Kramer, J.1
  • 37
    • 0022555299 scopus 로고
    • Incidence and clinical feature of the quinidine-associated long QT syndrome: Implications for patient care
    • DOI 10.1016/0002-8703(86)90010-4
    • Roden, D.M., Woosley, R.L. & Primm, R.K. Incidence and clinical features of the quinidine-associated long QT syndrome: implications for patient care. Am. Heart J. 111, 1088-1093 (1986). (Pubitemid 16085013)
    • (1986) American Heart Journal , vol.111 , Issue.6 , pp. 1088-1093
    • Roden, D.M.1    Woosley, R.L.2    Primm, R.K.3
  • 38
    • 84860376625 scopus 로고    scopus 로고
    • Suppression of phosphoinositide 3-kinase signaling and alteration of multiple ion currents in drug-induced long QT syndrome
    • Lu, Z. et al. Suppression of phosphoinositide 3-kinase signaling and alteration of multiple ion currents in drug-induced long QT syndrome. Sci. Transl. Med. 4, 131ra50 (2012).
    • (2012) Sci. Transl. Med. , vol.4
    • Lu, Z.1
  • 39
    • 84899446063 scopus 로고    scopus 로고
    • FDA seeks alternatives to QT interval for assessing risk of torsade de pointes
    • Dombrowski, C. FDA seeks alternatives to QT interval for assessing risk of torsade de pointes. In: The Pink Sheet. 〈http://www.elsevierbi.com/ publications/the-pink-sheet/75/26/fda-seeks-alternatives-to-qt-interval-for- assessing-risk-of-torsade-de-pointes〉 (2013).
    • (2013) The Pink Sheet.
    • Dombrowski, C.1
  • 40
    • 84877782905 scopus 로고    scopus 로고
    • Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies
    • Chen, J. et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 144, 1450-1455.e2 (2013).
    • (2013) Gastroenterology , vol.144
    • Chen, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.