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Volumn 89, Issue 1, 2011, Pages 75-80

Comparison of QTc data analysis methods recommended by the ich E14 guidance and exposure-response analysis: Case study of a thorough QT study of asenapine

Author keywords

[No Author keywords available]

Indexed keywords

ASENAPINE; PLACEBO; QUETIAPINE;

EID: 78650516508     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.220     Document Type: Article
Times cited : (28)

References (9)
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    • US Food and Drug administration. International Conference on Harmonisation; Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs; availability
    • US Food and Drug administration. International Conference on Harmonisation; Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs; availability. Notice. Fed. Regist. 70, 61134-61135 (2005).
    • (2005) Notice. Fed. Regist. , vol.70 , pp. 61134-61135
  • 2
    • 33645790554 scopus 로고    scopus 로고
    • Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline
    • Darpo, B., Nebout, T. & Sager, P.T. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline. J. Clin. Pharmacol. 46, 498-507 (2006).
    • (2006) J. Clin. Pharmacol. , vol.46 , pp. 498-507
    • Darpo, B.1    Nebout, T.2    Sager, P.T.3
  • 3
    • 70350424361 scopus 로고    scopus 로고
    • Exposure-response analysis in patients with schizophrenia to assess the efect of asenapine on QTc prolongation
    • Chapel, S. et al. Exposure-response analysis in patients with schizophrenia to assess the efect of asenapine on QTc prolongation. J. Clin. Pharmacol. 49, 1297-1308 (2009).
    • (2009) J. Clin. Pharmacol. , vol.49 , pp. 1297-1308
    • Chapel, S.1
  • 4
    • 38349181606 scopus 로고    scopus 로고
    • Performance characteristics for some typical QT study designs under the ICH E-14 guidance
    • Hutmacher, M.M., Chapel, S., Agin, M.A., Fleishaker, J.C. & Lalonde, R.L. Performance characteristics for some typical QT study designs under the ICH E-14 guidance. J. Clin. Pharmacol. 48, 215-224 (2008).
    • (2008) J. Clin. Pharmacol. , vol.48 , pp. 215-224
    • Hutmacher, M.M.1    Chapel, S.2    Agin, M.A.3    Fleishaker, J.C.4    Lalonde, R.L.5
  • 5
    • 37349094191 scopus 로고    scopus 로고
    • A perspective on the use of concentration-QT modeling in drug development
    • Russell, T., Riley, S.P., Cook, J.A. & Lalonde, R.L. A perspective on the use of concentration-QT modeling in drug development. J. Clin. Pharmacol. 48, 9-12 (2008).
    • (2008) J. Clin. Pharmacol. , vol.48 , pp. 9-12
    • Russell, T.1    Riley, S.P.2    Cook, J.A.3    Lalonde, R.L.4
  • 6
    • 37349079996 scopus 로고    scopus 로고
    • Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review
    • Garnett, C.E. et al. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J. Clin. Pharmacol. 48, 13-18 (2008).
    • (2008) J. Clin. Pharmacol. , vol.48 , pp. 13-18
    • Garnett, C.E.1
  • 7
    • 77951684272 scopus 로고    scopus 로고
    • Response to letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by yi Tsong et al
    • author reply 693
    • Wang, Y. & Garnett, C. Response to letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by yi Tsong et al. J. Biopharm. Stat. 20, 689-692; author reply 693 (2010).
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 689-692
    • Wang, Y.1    Garnett, C.2
  • 8
    • 23844475352 scopus 로고    scopus 로고
    • Investigating drug-induced QT and QTc prolongation in the clinic: A review of statistical design and analysis considerations: Report from the Pharmaceutical Research and Manufacturers of america QT Statistics Expert Team
    • Patterson, S., Agin, M. & anziano, R. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations: report from the Pharmaceutical Research and Manufacturers of america QT Statistics Expert Team. Drug Inf. J. 39, 243-265 (2005).
    • (2005) Drug Inf. J. , vol.39 , pp. 243-265
    • Patterson, S.1    Agin, M.2    Anziano, R.3
  • 9
    • 34547464547 scopus 로고    scopus 로고
    • Saphris (asenapine sublingual tablets) Kenilworth, Nj: Schering-Plough
    • Saphris (asenapine sublingual tablets). Full prescribing information, Kenilworth, Nj: Schering-Plough, 2009.
    • (2009) Full Prescribing Information


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.