Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals.
第一作者:
David J,Snodin
第一单位:
PAREXEL Drug Development Consulting, Uxbridge, Middlesex, UK. david.snodin@parexel.com
作者:
医学主题词
动物(Animals);生物制品(Biological Products);生物技术(Biotechnology);临床试验(主题)(Clinical Trials as Topic);药物批准(Drug Approval);药物评价, 临床前(Drug Evaluation, Preclinical);欧盟(European Union);指导方针(主题)(Guidelines as Topic);人类(Humans);国际合作(International Cooperation);药用制剂(Pharmaceutical Preparations);美国(United States);美国食品和药物管理局(United States Food and Drug Administration);世界卫生组织(World Health Organization)
DOI
10.2165/00063030-200620010-00003
PMID
16573349
发布时间
2018-10-25
- 浏览28
BioDrugs
25-52页
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