Exposure-Response Modeling Approach for Assessing QT Effect in Thorough QT/QTc Studies

被引：3
|
作者：
Hosmane, Balakrishna [1 ]
Locke, Charles [2 ]
Chiu, Yi-Lin [2 ]
机构：
[1] No Illinois Univ, Div Stat, De Kalb, IL 60115 USA
[2] Abbott Labs, Abbott Pk, IL 60064 USA
来源：
JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2010年 / 20卷 / 03期
关键词：
Alternative strategy; Exposure-response model; Intersection-union test;
D O I：
10.1080/10543400903582026
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
We assess the QT effect using an exposure-response model in a othorough QT/QTc studyo with a four-period crossover design in which the treatments are placebo, positive control, higher dose of investigational drug, and therapeutic dose of investigational drug. In the study, QTc interval values and the drug concentrations are obtained for several specified times during treatment. This approach to the assessment of non-inferiority of the higher dose to placebo is an alternative strategy suggested in ICH-E14 guideline (Section 2.2.5) to the intersection-union test.
引用
收藏
页码：624 / 640
页数：17
相关论文
共 50 条
  • [31] Lamotrigine does not prolong QTC in a thorough QT/QTC study in healthy volunteers
    Maya, Juan F.
    Dixon, R. M.
    Job, S.
    Clement, L. O.
    Maltby, K.
    Lorch, U.
    EPILEPSIA, 2007, 48 : 360 - 360
  • [32] Assessing a Drug's Proarrhythmic Liability: An Overview of Computer Simulation Modeling, Nonclinical Assays, and the Thorough QT/QTc Study
    Satin, Lawrence Z.
    Durham, Todd A.
    Turner, J. Rick
    DRUG INFORMATION JOURNAL, 2011, 45 (03): : 357 - 375
  • [33] Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects
    Dixon, Ruth
    Job, Sarah
    Oliver, Ruth
    Tompson, Debra
    Wright, John G.
    Maltby, Kay
    Lorch, Ulrike
    Taubel, Jorg
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2008, 66 (03) : 396 - 404
  • [34] Evaluation of Opicapone on Cardiac Repolarization in a Thorough QT/QTc Study
    Pinto, Roberto
    l'Hostis, Philippe
    Patat, Alain
    Homery, Marie-Claude
    Falcao, Amilcar
    Nunes, Teresa
    Rocha, Jose-Francisco
    Soares-da-Silva, Patricio
    CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2015, 4 (06): : 454 - 462
  • [35] No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects
    Valentin Demmel
    Anne Sandberg-Schaal
    Jacob B. Jacobsen
    Georg Golor
    Jonas Pettersson
    Anne Flint
    Diabetes Therapy, 2018, 9 : 1441 - 1456
  • [36] The significance of thorough QT/QTc study in clinical drug development
    Kasanuki, H
    JOURNAL OF PHARMACOLOGICAL SCIENCES, 2004, 94 : 67P - 67P
  • [37] Statistical issues including design and sample size calculation in thorough QT/QTc studies
    Zhang, Joanne
    Machado, Stella G.
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2008, 18 (03) : 451 - 467
  • [38] Assay sensitivity in "Hybrid thorough QT/QTc (TQT)" study
    Huang, Dalong Patrick
    Chen, Janell
    Dang, Qianyu
    Tsong, Yi
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2019, 29 (02) : 378 - 384
  • [39] Evaluation of opicapone on cardiac repolarization in a thorough QT/QTc study
    Pinto, R.
    Vaz-da-Silva, M.
    Lopes, N.
    Santos, A.
    Nunes, T.
    Rocha, J. F.
    Soares-da-Silva, P.
    MOVEMENT DISORDERS, 2015, 30 : S112 - S112
  • [40] No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects
    Demmel, Valentin
    Sandberg-Schaal, Anne
    Jacobsen, Jacob B.
    Golor, Georg
    Pettersson, Jonas
    Flint, Anne
    DIABETES THERAPY, 2018, 9 (04) : 1441 - 1456
12345