Safety-related regulatory actions for biologicals approved in the United States and the European Union.
第一作者:
Thijs J,Giezen
第一单位:
Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, The Netherlands.
作者:
主题词
药物副反应报告系统(Adverse Drug Reaction Reporting Systems);生物制品(Biological Products);药物批准(Drug Approval);药物标签(Drug Labeling);欧盟(European Union);立法, 药物(Legislation, Drug);美国(United States)
DOI
10.1001/jama.300.16.1887
PMID
18940975
发布时间
2022-04-09
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JAMA
1887-96页
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