换一批
换一批摘要放射性药物在疾病的诊断、治疗、监测及药物的研发方面得到了广泛应用.美国食品与药品监督管理局(FDA)在放射性药物的管理方面有丰富的实践经验,该文从定义、法规、注册管理等方面对FDA的放射性药物管理政策进行解读,以期为国内放射性药物的研究提供参考.
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abstractsRadiopharmaceuticals have been widely used in the diagnosis, treatment and monitoring of diseases, and they play an important role in new drug development. Food and Drug Administration(FDA) has rich experience in the administration of radiopharmaceuticals. This article mainly interprets the regulato-ry policy of FDA for radiopharmaceuticals from the aspects of definition, regulations and registration, trying to provide reference for domestic research of radiopharmaceuticals.
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关键词
放射性药物美国食品和药物管理局药品和麻醉品检定发展趋势RadiopharmaceuticalsUnited States Food and Drug AdministrationDrug and narcotic controlTrends
主题词
放射性药物(Radiopharmaceuticals)组织和管理(Organization and Administration)美国(United States)美国食品和药物管理局(United States Food and Drug Administration)药品和麻醉品检定(Drug and Narcotic Control)
栏目名称
讲座
DOI
10.3760/cma.j.issn.2095-2848.2018.12.009
发布时间
2018-12-20
- 浏览408
- 被引8
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