Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2010 Jan;87(1):32-6. doi: 10.1038/clpt.2009.236.
The US Food and Drug Administration-led Critical Path Initiative, launched in 2004, has resulted in an array of activities focused on the sciences that support the development of human medical products.(1) These activities include the development of new scientific tools, such as in vitro testing, qualified biomarkers of drug safety, and innovative new methods in study design and data analysis.(2) As a result of the Critical Path Initiative and enormous advances in the field of membrane transporters, the International Transporter Consortium was formed.
美国食品和药物管理局(FDA)于 2004 年发起的关键路径倡议(Critical Path Initiative)已促成一系列专注于支持人类医疗产品开发的科学活动。(1)这些活动包括开发新的科学工具,如体外测试、药物安全的合格生物标志物以及研究设计和数据分析方面的创新新方法。(2)由于关键路径倡议和膜转运体领域的巨大进步,国际转运体联盟(International Transporter Consortium)成立。