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生物标志物:临床研究和医学实践中的一项宝贵工具。

Biomarkers: a valuable tool in clinical research and medical practice.

作者信息

Carini Claudio

机构信息

Tranlational Medicine, MDS Pharma Services, 2200 Renaissance Boulevard, King of Prussia, PA 19406-2755, USA.

出版信息

IDrugs. 2007 Jun;10(6):395-8.

Abstract

The importance of biomarker technology and biomarker strategies in pharmaceutical development is still in its infancy, but the impact of biomarkers is already proving to be significant in this field. Strategies for incorporating biomarkers form the basis for translational medicine and also for the industry/regulatory focus on reducing the high attrition rate of drugs often encountered at phase II clinical research. The depth and breadth of knowledge required to successfully implement biomarkers into drug development are generating many collaborative efforts within the pharmaceutical industry, as well as encouraging the involvement of professionals who traditionally have not been part of the drug-development process.

摘要

生物标志物技术和生物标志物策略在药物研发中的重要性仍处于起步阶段,但生物标志物的影响在该领域已被证明意义重大。纳入生物标志物的策略构成了转化医学的基础,也是行业/监管机构关注降低II期临床研究中经常出现的高药物淘汰率的基础。在药物研发中成功应用生物标志物所需知识的深度和广度,正在制药行业内催生诸多合作努力,同时也鼓励传统上未参与药物研发过程的专业人员参与其中。

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