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Volumn 160, Issue 4, 2010, Pages 627-634

Electrocardiographic assessment for therapeutic proteins-scientific discussion

(16)  Rodriguez, Ignacio a   Erdman, Andrew b   Padhi, Desmond b   Garnett, Christine E c   Zhao, Hong c   Targum, Shari L c   Balakrishnan, Suchitra c   Strnadova, Colette d   Viner, Norman d   Geiger, Mary Jane e   Newton Cheh, Christopher f,g   Litwin, Jeffrey h   Pugsley, Michael K i   Sager, Philip T j   Krucoff, Mitchell W k   Finkle, John K l  


Author keywords

[No Author keywords available]

Indexed keywords

BIVALURIDIN; BLOOD CLOTTING FACTOR; BOTULINUM TOXIN; ERYTHROPOIETIN; FILGASTRIM; GEMTUZUMAB OZOGAMICIN; GROWTH HORMONE; HEPATITIS B SURFACE ANTIGEN; IBRITUMOMAB TIUXETAN; IMMUNOGLOBULIN; INSULIN; INTERFERON; MONOCLONAL ANTIBODY; OXYTOCIN; RHESUS ANTIBODY; STREPTOKINASE; THYROTROPIN; TUBERCULIN; UNCLASSIFIED DRUG; VASOPRESSIN; WART VIRUS VACCINE; PROTEIN;

EID: 77957830531     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2010.07.001     Document Type: Review
Times cited : (33)

References (37)
  • 1
    • 33644832519 scopus 로고    scopus 로고
    • Long QT syndrome: Reduced repolarization reserve and the genetic link
    • Roden D.M. Long QT syndrome: reduced repolarization reserve and the genetic link J Intern Med 259 2006 59 69
    • (2006) J Intern Med , vol.259 , pp. 59-69
    • Roden, D.M.1
  • 2
    • 36448970843 scopus 로고    scopus 로고
    • Cardiac repolarisation and drug regulation: Assessing cardiac safety 10 years after the CPMP guidance
    • Shah R.R. Cardiac repolarisation and drug regulation: assessing cardiac safety 10 years after the CPMP guidance Drug Saf 30 2007 1093 1110
    • (2007) Drug Saf , vol.30 , pp. 1093-1110
    • Shah, R.R.1
  • 4
    • 84928697529 scopus 로고    scopus 로고
    • ICH S7B. The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
    • ICH Expert Working Group
    • ICH Expert Working Group ICH S7B. The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals International Conference on Harmonisation step 4 guideline, EMEA, CHMP/ICH/12/05 2005 Available at: http://www.ich.org/LOB/media/ MEDIA2192.pdf Last accessed June 24, 2010
    • (2005) International Conference on Harmonisation Step 4 Guideline, EMEA, CHMP/ICH/12/05
  • 5
    • 48149092512 scopus 로고    scopus 로고
    • Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics
    • Vargas H.M., Bass A.S., and Breidenbach A. Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics J Pharmacol Toxicol Methods 58 2008 72 76
    • (2008) J Pharmacol Toxicol Methods , vol.58 , pp. 72-76
    • Vargas, H.M.1    Bass, A.S.2    Breidenbach, A.3
  • 6
    • 37749004225 scopus 로고    scopus 로고
    • Protein therapeutics: A summary and pharmacological classification
    • Leader B., Baca Q.J., and Golan D.E. Protein therapeutics: a summary and pharmacological classification Nat Rev Drug Discov 7 2008 21 39
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 21-39
    • Leader, B.1    Baca, Q.J.2    Golan, D.E.3
  • 7
    • 33645317063 scopus 로고    scopus 로고
    • HERG potassium channels and cardiac arrhythmia
    • Sanguinetti M.C., and Tristani-Firouzi M. hERG potassium channels and cardiac arrhythmia Nature 440 2006 463 469
    • (2006) Nature , vol.440 , pp. 463-469
    • Sanguinetti, M.C.1    Tristani-Firouzi, M.2
  • 8
    • 47549086709 scopus 로고    scopus 로고
    • HERG potassium channels and the structural basis of drug-induced arrhythmias
    • Mitcheson J.S. hERG potassium channels and the structural basis of drug-induced arrhythmias Chem Res Toxicol 21 2008 1005 1010
    • (2008) Chem Res Toxicol , vol.21 , pp. 1005-1010
    • Mitcheson, J.S.1
  • 9
    • 0038523849 scopus 로고    scopus 로고
    • BeKm-1 is a HERG-specific toxin that shares the structure with ChTx but the mechanism of action with ErgTx1
    • Zhang M., Korolkova Y.V., and Liu J. BeKm-1 is a HERG-specific toxin that shares the structure with ChTx but the mechanism of action with ErgTx1 Biophys J 84 2003 3022 3036
    • (2003) Biophys J , vol.84 , pp. 3022-3036
    • Zhang, M.1    Korolkova, Y.V.2    Liu, J.3
  • 10
    • 1842778909 scopus 로고    scopus 로고
    • Impairment of HERG K(+) channel function by tumor necrosis factor-alpha: Role of reactive oxygen species as a mediator
    • Wang J., Wang H., and Zhang Y. Impairment of HERG K(+) channel function by tumor necrosis factor-alpha: role of reactive oxygen species as a mediator J Biol Chem 279 2004 13289 13292
    • (2004) J Biol Chem , vol.279 , pp. 13289-13292
    • Wang, J.1    Wang, H.2    Zhang, Y.3
  • 12
    • 0029006025 scopus 로고
    • Torsade de pointes complicating the treatment of bleeding esophageal varices: Association with neuroleptics, vasopressin, and electrolyte imbalance
    • Faigel D.O., Metz D.C., and Kochman M.L. Torsade de pointes complicating the treatment of bleeding esophageal varices: association with neuroleptics, vasopressin, and electrolyte imbalance Am J Gastroenterol 90 1995 822 824
    • (1995) Am J Gastroenterol , vol.90 , pp. 822-824
    • Faigel, D.O.1    Metz, D.C.2    Kochman, M.L.3
  • 13
    • 0023898168 scopus 로고
    • Torsade de pointes in a patient receiving intravenous vasopressin
    • Mauro V.F., Bingle J.F., and Ginn S.M. Torsade de pointes in a patient receiving intravenous vasopressin Crit Care Med 16 1988 200 201
    • (1988) Crit Care Med , vol.16 , pp. 200-201
    • Mauro, V.F.1    Bingle, J.F.2    Ginn, S.M.3
  • 14
    • 0032012483 scopus 로고    scopus 로고
    • Ventricular tachycardia after oxytocin injection in patients with prolonged Q-T interval syndrome-report of two cases
    • Liou S.C., Chen C., and Wong S.Y. Ventricular tachycardia after oxytocin injection in patients with prolonged Q-T interval syndrome-report of two cases Acta Anaesthesiol Sin 36 1998 49 52
    • (1998) Acta Anaesthesiol Sin , vol.36 , pp. 49-52
    • Liou, S.C.1    Chen, C.2    Wong, S.Y.3
  • 15
    • 4744346626 scopus 로고    scopus 로고
    • QT interval prolongation after oxytocin bolus during surgical induced abortion
    • Charbit B., Funck-Brentano C., and Samain E. QT interval prolongation after oxytocin bolus during surgical induced abortion Clin Pharmacol Ther 76 2004 359 364
    • (2004) Clin Pharmacol Ther , vol.76 , pp. 359-364
    • Charbit, B.1    Funck-Brentano, C.2    Samain, E.3
  • 16
    • 33746035691 scopus 로고    scopus 로고
    • Cardiotoxicity of histone deacetylase inhibitor depsipeptide in patients with metastatic neuroendocrine tumors
    • Shah M.H., Binkley P., and Chan K. Cardiotoxicity of histone deacetylase inhibitor depsipeptide in patients with metastatic neuroendocrine tumors Clin Cancer Res 12 2006 3997 4003
    • (2006) Clin Cancer Res , vol.12 , pp. 3997-4003
    • Shah, M.H.1    Binkley, P.2    Chan, K.3
  • 17
    • 35348851892 scopus 로고    scopus 로고
    • The acute effect of trastuzumab infusion on ECG parameters in metastatic breast cancer patients
    • Yavas O., Yazici M., and Eren O. The acute effect of trastuzumab infusion on ECG parameters in metastatic breast cancer patients Swiss Med Wkly 137 2007 556 558
    • (2007) Swiss Med Wkly , vol.137 , pp. 556-558
    • Yavas, O.1    Yazici, M.2    Eren, O.3
  • 18
    • 43849094005 scopus 로고    scopus 로고
    • Cardiotoxicity profile of trastuzumab
    • Ewer S.M., and Ewer M.S. Cardiotoxicity profile of trastuzumab Drug Saf 31 2008 459 467
    • (2008) Drug Saf , vol.31 , pp. 459-467
    • Ewer, S.M.1    Ewer, M.S.2
  • 19
    • 35349005677 scopus 로고    scopus 로고
    • Anti-KCNH2 antibody-induced long QT syndrome: Novel acquired form of long QT syndrome
    • Nakamura K., Katayama Y., and Kusano K.F. Anti-KCNH2 antibody-induced long QT syndrome: novel acquired form of long QT syndrome J Am Coll Cardiol 50 2007 1808 1809
    • (2007) J Am Coll Cardiol , vol.50 , pp. 1808-1809
    • Nakamura, K.1    Katayama, Y.2    Kusano, K.F.3
  • 20
    • 40249094483 scopus 로고    scopus 로고
    • Drug-induced QTc interval prolongation: A proposal towards an efficient and safe anticancer drug development
    • Curigliano G., Spitaleri G., and Fingert H.J. Drug-induced QTc interval prolongation: a proposal towards an efficient and safe anticancer drug development Eur J Cancer 44 2008 494 500
    • (2008) Eur J Cancer , vol.44 , pp. 494-500
    • Curigliano, G.1    Spitaleri, G.2    Fingert, H.J.3
  • 21
    • 44949175102 scopus 로고    scopus 로고
    • Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents
    • Sarapa N., and Britto M.R. Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents Expert Opin Drug Saf 7 2008 305 318
    • (2008) Expert Opin Drug Saf , vol.7 , pp. 305-318
    • Sarapa, N.1    Britto, M.R.2
  • 22
    • 64349093768 scopus 로고    scopus 로고
    • Assessing proarrhythmic potential of drugs when optimal studies are infeasible
    • Rock E.P., Finkle J., and Fingert H.J. Assessing proarrhythmic potential of drugs when optimal studies are infeasible Am Heart J 157 2009 827 836e1
    • (2009) Am Heart J , vol.157
    • Rock, E.P.1    Finkle, J.2    Fingert, H.J.3
  • 23
    • 54249121649 scopus 로고    scopus 로고
    • Safety issues specific to clinical development of protein therapeutics
    • Haller C., Cosenza M., and Sullivan J. Safety issues specific to clinical development of protein therapeutics Clin Pharmacol Ther 84 2008 624 627
    • (2008) Clin Pharmacol Ther , vol.84 , pp. 624-627
    • Haller, C.1    Cosenza, M.2    Sullivan, J.3
  • 24
    • 14544286345 scopus 로고    scopus 로고
    • Risks and benefits of phase 1 oncology trials, revisited
    • DOI 10.1056/NEJMe058007
    • Kurzrock R., and Benjamin R.S. Risks and benefits of phase 1 oncology trials, revisited N Engl J Med 352 2005 930 932 (Pubitemid 40300304)
    • (2005) New England Journal of Medicine , vol.352 , Issue.9 , pp. 930-932
    • Kurzrock, R.1    Benjamin, R.S.2
  • 25
    • 45849094068 scopus 로고    scopus 로고
    • Statistical issues including design and sample size calculation
    • Zhang J., and Machado G.S. Statistical issues including design and sample size calculation J Biopharm Statist 18 2008 451 467
    • (2008) J Biopharm Statist , vol.18 , pp. 451-467
    • Zhang, J.1    MacHado, G.S.2
  • 26
    • 43149089348 scopus 로고    scopus 로고
    • Localization of the ergtoxin-1 receptors on the voltage sensing domain of hERG K+ channel by AFM recognition imaging
    • Chtcheglova L.A. Localization of the ergtoxin-1 receptors on the voltage sensing domain of hERG K+ channel by AFM recognition imaging Pflugers Arch 456 2008 247 254
    • (2008) Pflugers Arch , vol.456 , pp. 247-254
    • Chtcheglova, L.A.1
  • 27
    • 24344507278 scopus 로고    scopus 로고
    • Drug-conjugated monoclonal antibodies for the treatment of cancer
    • Lambert J.M. Drug-conjugated monoclonal antibodies for the treatment of cancer Curr Opin Pharmacol 5 2005 543 549
    • (2005) Curr Opin Pharmacol , vol.5 , pp. 543-549
    • Lambert, J.M.1
  • 28
    • 60849128549 scopus 로고    scopus 로고
    • Monoclonal antibodies as innovative therapeutics
    • Reichert J.M. Monoclonal antibodies as innovative therapeutics Curr Pharm Biotechnol 9 2008 423 430
    • (2008) Curr Pharm Biotechnol , vol.9 , pp. 423-430
    • Reichert, J.M.1
  • 29
    • 37349079996 scopus 로고    scopus 로고
    • Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review
    • Garnett C.E., Beasley N., and Bhattaram V.A. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review J Clin Pharmacol 48 2008 13 18
    • (2008) J Clin Pharmacol , vol.48 , pp. 13-18
    • Garnett, C.E.1    Beasley, N.2    Bhattaram, V.A.3
  • 30
    • 33646654192 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation
    • Piotrovsky V. Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation AAPS J 7 2005 E609 624
    • (2005) AAPS J , vol.7 , pp. 609-624
    • Piotrovsky, V.1
  • 31
    • 0027769745 scopus 로고
    • Comparison of four basic models of indirect pharmacodynamic responses
    • Dayneka N.L., Garg V., and Jusko W.J. Comparison of four basic models of indirect pharmacodynamic responses J Pharmacokinet Biopharm 21 1993 457 478
    • (1993) J Pharmacokinet Biopharm , vol.21 , pp. 457-478
    • Dayneka, N.L.1    Garg, V.2    Jusko, W.J.3
  • 32
    • 0018394195 scopus 로고
    • Simultaneous modeling of pharmacokinetics and pharmacodynamics: Application to d-tubocurarine
    • Sheiner L.B., Stanski D.R., and Vozeh S. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine Clin Pharmacol Ther 25 1979 358 371
    • (1979) Clin Pharmacol Ther , vol.25 , pp. 358-371
    • Sheiner, L.B.1    Stanski, D.R.2    Vozeh, S.3
  • 33
    • 33846219021 scopus 로고    scopus 로고
    • Mathematical modeling as accounting: Predicting the fate of serum proteins and therapeutic monoclonal antibodies
    • Gurbaxani B. Mathematical modeling as accounting: predicting the fate of serum proteins and therapeutic monoclonal antibodies Clin Immunol 122 2007 121 124
    • (2007) Clin Immunol , vol.122 , pp. 121-124
    • Gurbaxani, B.1
  • 34
    • 34548276036 scopus 로고    scopus 로고
    • Molecularly targeted oncology therapeutics and prolongation of the QT interval
    • Strevel E.L., Ing D.J., and Siu L.L. Molecularly targeted oncology therapeutics and prolongation of the QT interval J Clin Oncol 25 2007 3362 3371
    • (2007) J Clin Oncol , vol.25 , pp. 3362-3371
    • Strevel, E.L.1    Ing, D.J.2    Siu, L.L.3


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