对医学研究所报告《药物安全的未来》的回顾与评论

Review and critique of the Institute of Medicine report "the future of drug safety".

作者信息

Benet L Z

机构信息

Department of Biopharmaceutical Sciences, University of California San Francisco, San Francisco, California, USA.

出版信息

Clin Pharmacol Ther. 2007 Feb;81(2):158-61. doi: 10.1038/sj.clpt.6100083.

DOI:10.1038/sj.clpt.6100083

PMID:17259941

Abstract

In September 2006 an Institute of Medicine (IOM) ad hoc committee on the Assessment of the US Drug Safety System released its report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public". The committee's report includes 25 recommendations that "will bring the strengths of the preapproval process (data, regulatory authority, organizational function and capabilities, and resources) to the postapproval phase in order to fulfill a lifecycle approach to the study, regulation, and communication about the risks and benefits of drugs." Copies of the report are available from the National Academies Press (800-624-6242), and the full text is available at http://www.nap.edu.

摘要

2006年9月，美国医学研究所（IOM）药物安全系统评估特设委员会发布了题为《药物安全的未来：促进和保护公众健康》的报告。该委员会的报告包含25项建议，“将把审批前程序的优势（数据、监管机构、组织功能与能力以及资源）应用于审批后阶段，以实现对药物风险和益处进行研究、监管及信息交流的全生命周期方法”。该报告副本可从美国国家科学院出版社获取（电话：800 - 624 - 6242），完整文本可在http://www.nap.edu查阅。