The common technical document, module 3-regulatory and scientific aspects of the drug product section

被引:0
|
作者
Eijgenhuijsen, P
DiFeo, TJ
机构
[1] Johnson & Johnson Pharmaceut Res & Dev, CMC Sci & Dossier Management, Beerse, Belgium
[2] Johnson & Johnson Pharmaceut Res & Dev, CMC Sci & Dossier Management, Spring House, PA USA
关键词
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
引用
收藏
页码:S77 / S77
页数:1
相关论文
共 18 条
  • [1] Regulatory and Scientific Aspects of Drug-Drug Interaction Studies
    Greenblatt, David J.
    [J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2012, 1 (02): : 43 - +
  • [2] SPECIAL SECTION - TECHNICAL AND SCIENTIFIC ASPECTS OF MST RADAR - FOREWORD
    LIU, CH
    FUKAO, S
    [J]. RADIO SCIENCE, 1990, 25 (05) : 897 - 897
  • [3] A generic drug primer: Regulatory aspects and scientific concepts
    Henderson, JD
    White, GL
    [J]. MILITARY MEDICINE, 1998, 163 (04) : 193 - 197
  • [4] The electronic common technical document - Transition to a new paradigm in regulatory submissions
    Cook, J
    [J]. BIOPHARM INTERNATIONAL-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT, 2003, : 24 - 27
  • [5] The common technical document: the changing face of the new drug application
    Molzon, J
    [J]. NATURE REVIEWS DRUG DISCOVERY, 2003, 2 (01) : 71 - 74
  • [6] The Common Technical Document: the changing face of the New Drug Application
    Justina Molzon
    [J]. Nature Reviews Drug Discovery, 2003, 2 : 71 - 74
  • [7] From Cell to Product/Technical and regulatory aspects of the biotechnological production of monoclonal antibodies
    Sindelar, Georg
    [J]. PHARMAZEUTISCHE INDUSTRIE, 2013, 75 (02): : 334 - 339
  • [8] Drug use in horses and identification document - Regulatory aspects since July 2000
    Kluge, K
    Ungemach, FR
    [J]. TIERARZTLICHE PRAXIS AUSGABE GROBTIERE NUTZTIERE, 2001, 29 (02): : 57 - 60
  • [9] 3D DOCUMENT - THE NEW TYPE OF THE SCIENTIFIC AND TECHNICAL DOCUMENTATION
    Leonov, A., V
    Baturin, Yu. M.
    [J]. HERALD OF AN ARCHIVIST, 2013, (02): : 192 - 203
  • [10] Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development
    Li, Min
    Sander, Sanna
    Duan, John
    Rosencrance, Susan
    Miksinski, Sarah Pope
    Yu, Lawrence
    Seo, Paul
    Rege, Bhagwant
    [J]. AAPS JOURNAL, 2016, 18 (06): : 1406 - 1417