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关键路径研究所的前竞争共享和推进监管科学方法。

The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.

机构信息

Critical Path Institute, Tucson, Arizona, USA.

出版信息

Clin Pharmacol Ther. 2010 May;87(5):530-3. doi: 10.1038/clpt.2010.27.

Abstract

Many successful large industries, such as computer-chip manufacturers, the cable television industry, and high-definition television developers,(1) have established successful precompetitive collaborations focusing on standards, applied science, and technology that advance the field for all stakeholders and benefit the public.(2) The pharmaceutical industry, however, has a well-earned reputation for fierce competition and did not demonstrate willingness to share data or knowledge until the US Food and Drug Administration (FDA) launched the Critical Path Initiative in 2004 (ref. 3).

摘要

许多成功的大型产业,如计算机芯片制造商、有线电视行业和高清电视开发商,(1)建立了成功的竞争前合作关系,专注于标准、应用科学和技术,为所有利益相关者推进该领域,并使公众受益。(2)然而,制药行业以激烈的竞争而闻名,直到美国食品和药物管理局(FDA)在 2004 年启动关键路径倡议(参考文献 3),才表现出愿意分享数据或知识。

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