Pharmacogenomics and regulatory decision making: an international perspective

被引:0
|
作者
D L Mendrick
C Brazell
E A Mansfield
R Pietrusko
I Barilero
J Hackett
S Stürzebecher
D Jacobson-Kram
机构
[1] Toxicogenomics,
[2] Gene Logic Inc.,undefined
[3] Genetics Research,undefined
[4] GlaxoSmithKline,undefined
[5] Regulatory Affairs,undefined
[6] Affymetrix Inc.,undefined
[7] Worldwide Regulatory Affairs,undefined
[8] Millennium Pharmaceuticals,undefined
[9] Inc.,undefined
[10] Global Regulatory Policy and Intelligence,undefined
[11] Johnson & Johnson Pharmaceutical Research and Development,undefined
[12] Office of In Vitro Diagnostic Device Evaluation and Safety,undefined
[13] CDRH,undefined
[14] Corporate Preclinical Development,undefined
[15] Office of New Drugs,undefined
[16] CDER,undefined
来源
关键词
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:154 / 157
页数:3
相关论文
共 50 条
  • [1] Pharmacogenomics and regulatory decision making:: an international perspective
    Mendrick, DL
    Brazell, C
    Mansfield, EA
    Pietrusko, R
    Barilero, I
    Hackett, J
    Stürzebecher, S
    Jacobson-Kram, D
    PHARMACOGENOMICS JOURNAL, 2006, 6 (03): : 154 - 157
  • [2] Pharmacometrics for Regulatory Decision Making Status and Perspective
    Manolis, Efthymios
    Herold, Ralf
    CLINICAL PHARMACOKINETICS, 2011, 50 (10) : 625 - 626
  • [3] The need for education in pharmacogenomics: a regulatory perspective
    F W Frueh
    F Goodsaid
    A Rudman
    S-M Huang
    L J Lesko
    The Pharmacogenomics Journal, 2005, 5 : 218 - 220
  • [4] Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective
    Lawrence J. Lesko
    Janet Woodcock
    Nature Reviews Drug Discovery, 2004, 3 : 763 - 769
  • [5] The need for education in pharmacogenomics: a regulatory perspective
    Frueh, FW
    Goodsaid, F
    Rudman, A
    Huang, SM
    Lesko, LJ
    PHARMACOGENOMICS JOURNAL, 2005, 5 (04): : 218 - 220
  • [6] Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective
    Lesko, LJ
    Woodcock, J
    NATURE REVIEWS DRUG DISCOVERY, 2004, 3 (09) : 763 - 769
  • [7] Invited Perspective: Advancing Cumulative Approaches in Regulatory Decision Making
    Chiger, Andrea A.
    Nachman, Keeve E.
    ENVIRONMENTAL HEALTH PERSPECTIVES, 2024, 132 (03)
  • [8] Pharmacogenomics in drug development and regulatory decision-making: the genomic data submission (GDS) proposal
    Salerno, RA
    Lesko, LJ
    PHARMACOGENOMICS, 2004, 5 (01) : 25 - 30
  • [9] Integration of Pharmacogenetics and Pharmacogenomics in Drug Development: Implications for Regulatory and Medical Decision Making in Pediatric Diseases
    Piana, Chiara
    Surh, Linda
    Furst-Recktenwald, Sabine
    Iolascon, Achille
    Jacqz-Aigrain, Evelyne M.
    Jonker, In Eke
    Russo, Roberta
    van Schalk, Ron H. N.
    Wessels, Judith
    Della Pasqua, Oscar E.
    JOURNAL OF CLINICAL PHARMACOLOGY, 2012, 52 (05): : 704 - 716
  • [10] The reality of pharmacogenomics: Optimizing therapeutic decision making
    Lee, CR
    Zeldin, DC
    ENVIRONMENTAL HEALTH PERSPECTIVES, 2003, 111 (11) : A566 - A567