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Volumn 350, Issue 2, 2014, Pages 469-478

Prediction and modeling of effects on the QTc interval for clinical safety margin assessment, based on single-ascending-dose study data with AZD3839

(16)  Sparve, Erik a   Quartino, Angelica L b   Lüttgen, Maria c   Tunblad, Karin d   Gårdlund, Anna Teiling e   Fälting, Johanna f   Alexander, Robert g   Kågström, Jens h   Sjödin, Linnea i   Bulgak, Alexander c   Al Saffar, Ahmad j   Bridgland Taylor, Matthew g   Pollard, Chris g   Swedberg, Michael D B k   Vik, Torbjörn l   Paulsson, Björn m  


Author keywords

[No Author keywords available]

Indexed keywords

AZD 3839; BETA SECRETASE INHIBITOR; UNCLASSIFIED DRUG; [1 [2 (DIFLUOROMETHYL)PYRIDIN 4 YL] 4 FLUORO 1 [3 (PYRIMIDIN 5 YL)PHENYL] 1H ISOINDOL 3 AMINE HEMIFUMARATE];

EID: 84904990379     PISSN: 00223565     EISSN: 15210103     Source Type: Journal    
DOI: 10.1124/jpet.114.215202     Document Type: Article
Times cited : (12)

References (26)
  • 1
    • 79957451960 scopus 로고    scopus 로고
    • Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models
    • Bergstrand M, Hooker AC, Wallin JE, and Karlsson MO (2011) Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 13: 143-151.
    • (2011) AAPS J , vol.13 , pp. 143-151
    • Bergstrand, M.1    Hooker, A.C.2    Wallin, J.E.3    Karlsson, M.O.4
  • 3
    • 0034231822 scopus 로고    scopus 로고
    • Drugs that prolong QT interval as an unwanted effect: Assessing their likelihood of inducing hazardous cardiac dysrhythmias
    • Cavero I, Mestre M, Guillon J-M, and Crumb W (2000) Drugs that prolong QT interval as an unwanted effect: assessing their likelihood of inducing hazardous cardiac dysrhythmias. Expert Opin Pharmacother 1:947-973.
    • (2000) Expert Opin Pharmacother , vol.1 , pp. 947-973
    • Cavero, I.1    Mestre, M.2    Guillon, J.-M.3    Crumb, W.4
  • 5
    • 84980098899 scopus 로고
    • The duration of systole in the electrocardiogram of normal subjects and of patients with heart disease
    • Fridericia LS (1920) The duration of systole in the electrocardiogram of normal subjects and of patients with heart disease. Acta Med Scand 53:469-486.
    • (1920) Acta Med Scand , vol.53 , pp. 469-486
    • Fridericia, L.S.1
  • 6
    • 79151474418 scopus 로고    scopus 로고
    • An evaluation of hERG current assay performance: Translating preclinical safety studies to clinical QT prolongation
    • Gintant G (2011) An evaluation of hERG current assay performance: translating preclinical safety studies to clinical QT prolongation. Pharmacol Ther 129: 109-119.
    • (2011) Pharmacol Ther , vol.129 , pp. 109-119
    • Gintant, G.1
  • 8
    • 34548528160 scopus 로고    scopus 로고
    • Evaluation of the Guinea pig monophasic action potential (MAP) assay in predicting drug-induced delay of ventricular repolarisation using 12 clinically documented drugs
    • Kågström J, Sjögren E-L, and Ericson AC (2007) Evaluation of the guinea pig monophasic action potential (MAP) assay in predicting drug-induced delay of ventricular repolarisation using 12 clinically documented drugs. J Pharmacol Toxicol Methods 56:186-193.
    • (2007) J Pharmacol Toxicol Methods , vol.56 , pp. 186-193
    • Kågström, J.1    Sjögren, E.-L.2    Ericson, A.C.3
  • 11
    • 23944435458 scopus 로고    scopus 로고
    • PsN-Toolkit - A collection of computer intensive statistical methods for non-linear mixed effect modeling using NON-MEM
    • Lindbom L, Pihlgren P, and Jonsson EN (2005) PsN-Toolkit - a collection of computer intensive statistical methods for non-linear mixed effect modeling using NON-MEM. Comput Methods Programs Biomed 79:241-257.
    • (2005) Comput Methods Programs Biomed , vol.79 , pp. 241-257
    • Lindbom, L.1    Pihlgren, P.2    Jonsson, E.N.3
  • 13
    • 25444529765 scopus 로고    scopus 로고
    • Molecular physiology of cardiac repolarization
    • Nerbonne JM and Kass RS (2005) Molecular physiology of cardiac repolarization. Physiol Rev 85:1205-1253.
    • (2005) Physiol Rev , vol.85 , pp. 1205-1253
    • Nerbonne, J.M.1    Kass, R.S.2
  • 16
    • 84904990947 scopus 로고    scopus 로고
    • Population pharmacokinetic and pharmacodynamic analysis of plasma Aβ40 and Aβ42 following single oral doses of the BACE1 inhibitor AZD3839 to healthy volunteers
    • DOI: 10.1002/cpdd.130 [published ahead of print]
    • Quartino A, Huledal G, Sparve E, Lüttgen M, Bueters T, Karlsson P, Olsson T, Paraskos J, Maltby J, Claeson-Bohnstedt K, et al. (2014) Population pharmacokinetic and pharmacodynamic analysis of plasma Aβ40 and Aβ42 following single oral doses of the BACE1 inhibitor AZD3839 to healthy volunteers. Clin Pharmacol Drug Dev DOI: 10.1002/cpdd.130 [published ahead of print].
    • (2014) Clin Pharmacol Drug Dev
    • Quartino, A.1    Huledal, G.2    Sparve, E.3    Lüttgen, M.4    Bueters, T.5    Karlsson, P.6    Olsson, T.7    Paraskos, J.8    Maltby, J.9    Claeson-Bohnstedt, K.10
  • 17
    • 0344492207 scopus 로고    scopus 로고
    • 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
    • Redfern WS, Carlsson L, Davis AS, Lynch WG, MacKenzie I, Palethorpe S, Siegl PK, Strang I, Sullivan AT, and Wallis R, et al (2003) 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 58:32-45.
    • (2003) Cardiovasc Res , vol.58 , pp. 32-45
    • Redfern, W.S.1    Carlsson, L.2    Davis, A.S.3    Lynch, W.G.4    MacKenzie, I.5    Palethorpe, S.6    Siegl, P.K.7    Strang, I.8    Sullivan, A.T.9    Wallis, R.10
  • 18
    • 1442306232 scopus 로고    scopus 로고
    • Drug-induced prolongation of the QT interval
    • Roden DM (2004) Drug-induced prolongation of the QT interval. N Engl J Med 350: 1013-1022.
    • (2004) N Engl J Med , vol.350 , pp. 1013-1022
    • Roden, D.M.1
  • 19
    • 0041888478 scopus 로고    scopus 로고
    • Ionworks HT: A new high-throughput electrophysiology measurement platform
    • Schroeder K, Neagle B, Trezise DJ, and Worley J (2003) Ionworks HT: a new high-throughput electrophysiology measurement platform. J Biomol Screen 8:50-64.
    • (2003) J Biomol Screen , vol.8 , pp. 50-64
    • Schroeder, K.1    Neagle, B.2    Trezise, D.J.3    Worley, J.4
  • 22
    • 50249105403 scopus 로고    scopus 로고
    • Early clinical development: Evaluation of drug-induced torsades de pointes risk
    • Vik T, Pollard C, and Sager P (2008) Early clinical development: evaluation of drug-induced torsades de pointes risk. Pharmacol Ther 119:210-214.
    • (2008) Pharmacol Ther , vol.119 , pp. 210-214
    • Vik, T.1    Pollard, C.2    Sager, P.3
  • 23
    • 74549140187 scopus 로고    scopus 로고
    • Integrated risk assessment and predictive value to humans of non-clinical repolarization assays
    • Wallis RM (2010) Integrated risk assessment and predictive value to humans of non-clinical repolarization assays. Br J Pharmacol 159:115-121.
    • (2010) Br J Pharmacol , vol.159 , pp. 115-121
    • Wallis, R.M.1
  • 24
    • 0034774943 scopus 로고    scopus 로고
    • Drug block of I(kr): Model systems and relevance to human arrhythmias
    • Yang T, Snyders D, and Roden DM (2001) Drug block of I(kr): model systems and relevance to human arrhythmias. J Cardiovasc Pharmacol 38:737-744.
    • (2001) J Cardiovasc Pharmacol , vol.38 , pp. 737-744
    • Yang, T.1    Snyders, D.2    Roden, D.M.3
  • 25
    • 1242269757 scopus 로고    scopus 로고
    • Simultaneous vs sequential analysis for population PK/PD data I: Best-case performance
    • Zhang L, Beal SL, and Sheiner LB (2003) Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn 30:387-404.
    • (2003) J Pharmacokinet Pharmacodyn , vol.30 , pp. 387-404
    • Zhang, L.1    Beal, S.L.2    Sheiner, L.B.3
  • 26
    • 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 JC, and January CT (1999) Mechanism of block and identification of the verapamil binding domain to HERG potassium channels. Circ Res 84:989-998.
    • (1999) Circ Res , vol.84 , pp. 989-998
    • Zhang, S.1    Zhou, Z.2    Gong, Q.3    Makielski, J.C.4    January, C.T.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.