Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
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DOI：
10.1038/nbt.1625
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发表时间：
2010-05-01
影响因子：
46.9
通讯作者：
Mattes, William
中科院分区：
文献类型：
--
作者：
Dieterle, Frank;Sistare, Frank;Mattes, William
首个用于监管决策的安全生物标记物的正式资格标志着生物标记物在药物开发中的应用具有里程碑意义。在预测性安全测试联盟(PSTC)肾毒性工作组向食品和药物管理局(FDA)和欧洲药品管理局(EMEA)提交药物毒性研究和生物标记物性能分析后，七种肾脏安全生物标记物已获得在非临床和临床药物开发中有限使用的资格，以帮助指导安全性评估。这是一个试点过程，所获得的经验将有助于更好地了解资格鉴定过程可能如何演变，并澄清在特定背景下评估器官损伤生物标记物的表现所需的最低要求。
The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have been qualified for limited use in nonclinical and clinical drug development to help guide safety assessments. This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.