Predictivity of non-clinical repolarization assay data for clinical TQT data in FDA database

被引:1
|
作者
Valentin, Jean-Pierre [1 ]
Koerner, John [2 ]
Willard, James [2 ]
Park, Eun Jung [2 ]
Bi, Daoqin [2 ]
Link, William [2 ]
Fiszman, Monica [2 ]
Kozeli, Devi [2 ]
Skinner, Matt [1 ]
Cantilena, Louis [3 ]
Gintant, Gary [4 ]
Wisialowski, Todd [5 ]
Pettit, Syril [6 ]
Vargas, Hugo [7 ]
机构
[1] AstraZeneca, Chesire, England
[2] US FDA, Silver Spring, MD USA
[3] Uniformed Serv Univ Hlth Sci, Bethesda, MD 20814 USA
[4] Abbott, Abbott Pk, IL USA
[5] Pfizer, New York, NY USA
[6] ILSI HESI, Washington, DC USA
[7] Amgen Inc, Thousand Oaks, CA USA
关键词
D O I
10.1016/j.toxlet.2013.05.566
中图分类号
R99 [毒物学(毒理学)];
学科分类号
100405 ;
摘要
引用
收藏
页码:S232 / S233
页数:2
相关论文
共 50 条
  • [1] Predictivity of Non-Clinical Repolarization Assay Data for Clinical TQT Data in FDA Database
    Koerner, J.
    Valentin, J. P.
    Willard, J.
    Park, E. J.
    Bi, D.
    Link, W. T.
    Fiszman, M.
    Kozeli, D.
    Skinner, M.
    Vargas, H. M.
    Cantilena, L.
    Gintant, G.
    Wisialowski, T.
    Pettit, S.
    [J]. INTERNATIONAL JOURNAL OF TOXICOLOGY, 2013, 32 (01) : 63 - 63
  • [2] Pharmacogenomic data submissions to the FDA: non-clinical case studies
    Leighton, JK
    DeGeorge, J
    Jacobson-Kram, D
    MacGregor, J
    Mendrick, D
    Worobec, A
    [J]. PHARMACOGENOMICS, 2004, 5 (05) : 507 - 511
  • [3] Translatability of non-clinical and clinical imaging data to clinical efficacy
    de Boer, P.
    Langlois, X.
    Willems, L.
    Mannaert, E.
    Janssens, L.
    Streffer, J.
    van Nueten, L.
    Schmidt, M.
    [J]. FUNDAMENTAL & CLINICAL PHARMACOLOGY, 2008, 22 : 26 - 26
  • [4] A non-clinical and clinical IUCLID database for 530 phanmaceuticals
    Evangelisti, M.
    Parenti, M. D.
    Varchi, G.
    Franco, J.
    vom Brocke, J.
    Karamertzanis, P. G.
    Del Rio, A.
    Bichlmaier, I.
    [J]. NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY, 2024, 397 : S50 - S50
  • [5] Hepatic Effects of Duloxetine-I: Non-Clinical and Clinical Trial Data
    Wernicke, Joachim
    Pangallo, Beth
    Wang, Fujun
    Murray, Isabelle
    Henck, Judith W.
    Knadler, Mary Pat
    D'Souza, Deborah N.
    Uetrecht, Jack P.
    [J]. CURRENT DRUG SAFETY, 2008, 3 (02) : 132 - 142
  • [6] Normative data for the HADS from a large non-clinical sample
    Crawford, JR
    Henry, JD
    Crombie, C
    Taylor, EP
    [J]. BRITISH JOURNAL OF CLINICAL PSYCHOLOGY, 2001, 40 : 429 - 434
  • [7] Use of non-clinical and clinical data for the environmental risk assessment of Glybera (alipogene tiparvovec)
    Freidig, A.
    Salmon, F.
    Jenal, U.
    Petry, H.
    [J]. HUMAN GENE THERAPY, 2010, 21 (10) : 1401 - 1402
  • [8] PROTOCOL BASED NON-CLINICAL BIOMEDICAL LABORATORY DATA-COLLECTION
    OKANE, KC
    LEADERS, FE
    VANHOOSE, MC
    [J]. MEDICAL INFORMATICS, 1980, 5 (03): : 205 - 213
  • [9] Observing, spanning and shifting boundaries: working with data in non-clinical practice
    Sukovic, Suzana
    Eisner, Jamaica
    Duncanson, Kerith
    [J]. GLOBAL KNOWLEDGE MEMORY AND COMMUNICATION, 2024, 73 (4/5) : 496 - 520
  • [10] Association of clinical and non-clinical factors with subjective well-being - data of the SOHO study
    Karow, A
    Ritzhaupt, A
    Roesch, F
    Novick, D
    Naber, D
    Dittmann, RW
    [J]. PHARMACOPSYCHIATRY, 2003, 36 (05) : 239 - 239