First-in-human clinical trials: Comparison of EMEA and FDA guidelines

被引：0
|
作者：
Hernandez-Lopez, Candido [1 ]
机构：
[1] Labs Rubio, Dept Med I&D, Farmacol Clin, Barcelona, Spain
来源：
MEDICINA CLINICA | 2009年 / 132卷 / 01期
关键词：
HUMANS;
D O I：
10.1016/j.medcli.2008.10.022
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页码：30 / 34
页数：5
相关论文
共 50 条
  • [1] The EMEA Guideline on First-in-Human Clinical Trials and Its Impact on Pharmaceutical Development
    Milton, Mark N.
    Horvath, Christopher J.
    [J]. TOXICOLOGIC PATHOLOGY, 2009, 37 (03) : 363 - 371
  • [2] European regulations for first-in-human clinical trials
    Schriever, J.
    [J]. BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2007, 101 (05) : 363 - 363
  • [3] The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
    S Marchetti
    J H M Schellens
    [J]. British Journal of Cancer, 2007, 97 : 577 - 581
  • [4] The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
    Marchetti, S.
    Schellens, J. H. M.
    [J]. BRITISH JOURNAL OF CANCER, 2007, 97 (05) : 577 - 581
  • [5] 'First-in-human' trials overhauled
    不详
    [J]. SCIENCE, 2016, 353 (6298) : 429 - 429
  • [6] First-in-human clinical trial guidelines under review in EU
    [J]. Reactions Weekly, 2016, 1605 (1) : 2 - 2
  • [7] Support of first-in-human clinical trials with human in vitro toxicity testing
    Boonen, H. C.
    Beilmann, Mario
    Adkins, Karissa
    Boonen, Harrie
    Hewitt, Phil
    Hu, Wendy
    Mader, Robert
    Moore, Susanne
    Van Vleet, Terry
    Steger-Hartmann, Thomas
    Villenave, Remi
    [J]. TOXICOLOGY LETTERS, 2023, 384 : S36 - S36
  • [8] First-in-human clinical trials with vaccines—what regulators want
    Karen B Goetz
    Michael Pfleiderer
    Christian K Schneider
    [J]. Nature Biotechnology, 2010, 28 : 910 - 916
  • [9] Clinical pharmacology considerations for first-in-human clinical trials for enzyme replacement therapy
    Stern, Sydney
    Wang, Jie
    Li, Ruo-Jing
    Hon, Yuen Yi
    Weis, Shawna L.
    Wang, Yow-Ming C.
    Schuck, Robert
    Pacanowski, Michael
    [J]. JOURNAL OF INHERITED METABOLIC DISEASE, 2024,
  • [10] CLINICAL PHARMACOLOGY CONSIDERATIONS FOR FIRST-IN-HUMAN CLINICAL TRIALS FOR ENZYME REPLACEMENT THERAPY
    Stern, S.
    Wang, J.
    Li, R.
    Schuck, R.
    Pacanowski, M.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024, 115 : S108 - S109
12345