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首页> 外文期刊>Cytokine >In vitro cytokine release assays for predicting cytokine release syndrome: the current state-of-the-science. Report of a European Medicines Agency Workshop.
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In vitro cytokine release assays for predicting cytokine release syndrome: the current state-of-the-science. Report of a European Medicines Agency Workshop.

机译:用于预测细胞因子释放综合征的体外细胞因子释放测定:当前的科学水平。欧洲药品管理局研讨会的报告。

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摘要

Following the experience of the serious life-threatening TGN 1412-induced cytokine storm with multi-organ failure in healthy volunteers in March 2006 [1], significant progress on the understanding of the clinical events have been made. In order to improve the ability to predict a cytokine storm in support of first-in-human (FIH) studies, various groups have been working on different types of in vitro cytokine release assays (CRAs). A forum to discuss the state-of-the-science of CRAs was convened to discuss the assays and their use. Therefore, the European Medicines Agency sponsored a 1-day Workshop on November 19, 2009 to bring together regulatory, academic and industry scientists to share their experiences with the development and use of cytokine release assays to predict cytokine release syndrome (CRS) in humans. This workshop focused on: (1) the different types of assays being used, (2) validation studies on assay performance and predictive value, (3) how the assay data could be used to predict human risk and (4) future needs for assay improvement and new types of assays.
机译:继2006年3月在健康志愿者中经历严重威胁生命的TGN 1412诱发的多器官衰竭的细胞因子风暴[1]之后,在对临床事件的理解上取得了重大进展。为了提高支持人类首次进行(FIH)研究的预测细胞因子风暴的能力,各个小组一直在致力于不同类型的体外细胞因子释放测定(CRA)。召集了一个讨论CRA的最新科学技术的论坛来讨论这些检测方法及其用途。因此,欧洲药品管理局于2009年11月19日赞助了为期1天的研讨会,召集监管,学术和行业科学家共同分享他们在开发和使用细胞因子释放测定法预测人类细胞因子释放综合征(CRS)方面的经验。该研讨会的重点是:(1)使用的不同类型的测定;(2)关于测定性能和预测价值的验证研究;(3)如何将测定数据用于预测人的风险;以及(4)未来的测定需求改进和新型检测方法。

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