预测性安全测试联盟：关键路径的目标、挑战与成就综述
The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.
作者信息
Goodsaid Federico M, Frueh Felix W, Mattes William
机构信息
Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
出版信息
Drug Discov Today Technol. 2007 Winter;4(2):47-50. doi: 10.1016/j.ddtec.2007.10.010.
The qualification of biomarkers of drug safety requires data on many compounds and nonclinical and clinical studies. The cost and effort associated with these qualifications cannot be easily covered by a single pharmaceutical company. Intellectual property associated with safety biomarkers is also held by many different companies. Consortia between different pharmaceutical companies can overcome cost and intellectual property hurdles to biomarker qualification. The Predictive Safety Testing Consortium (PSTC) is a collaborative effort between 16 different pharmaceutical companies to generate data supporting biomarker qualification. This Consortium is coordinated through the C-Path Institute, and currently has five biomarker qualification working groups engaged in this collaboration: nephrotoxicity, hepatotoxicity, vascular injury, myopathy, and non-genotoxic carcinogenicity. These working groups are aided by a data management team and a translational strategy team. Qualification studies of promising biomarkers are already progressing in several of the working groups, and results in the nephrotoxicity working group warranted a data submission to the FDA and EMEA for regulatory qualification of new nephrotoxicity biomarkers.:
药物安全性生物标志物的鉴定需要许多化合物的数据以及非临床和临床研究的数据。单个制药公司很难轻易承担与这些鉴定相关的成本和工作。与安全性生物标志物相关的知识产权也由许多不同的公司持有。不同制药公司之间的联盟可以克服生物标志物鉴定中的成本和知识产权障碍。预测性安全测试联盟（PSTC）是16家不同制药公司之间的合作项目，旨在生成支持生物标志物鉴定的数据。该联盟由C-Path研究所协调，目前有五个生物标志物鉴定工作组参与此项合作：肾毒性、肝毒性、血管损伤、肌病和非基因毒性致癌性。这些工作组得到一个数据管理团队和一个转化策略团队的协助。几个工作组中对有前景的生物标志物的鉴定研究已经在进行中，肾毒性工作组的结果促使向美国食品药品监督管理局（FDA）和欧洲药品管理局（EMEA）提交数据，以对新的肾毒性生物标志物进行监管鉴定。
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