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推动新型结核病疫苗通过监管程序。

Moving new vaccines for tuberculosis through the regulatory process.

作者信息

Brennan M J

机构信息

Laboratory of Mycobacteria, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.

出版信息

Clin Infect Dis. 2000 Jun;30 Suppl 3:S247-9. doi: 10.1086/313869.

Abstract

The development of novel vaccines for the prevention of tuberculosis is an area of intense interest for scientific researchers, public health agencies, and pharmaceutical manufacturers. Development of effective new vaccines directed against tuberculosis for use in target populations will require close cooperation among several different international organizations, including regulatory agencies responsible for evaluating the safety and effectiveness of new biologics for human use.

摘要

开发用于预防结核病的新型疫苗是科研人员、公共卫生机构和制药企业极为关注的领域。针对目标人群研发有效的新型抗结核疫苗需要几个不同国际组织密切合作,包括负责评估人类使用新生物制品安全性和有效性的监管机构。

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