Animal models for medical countermeasures to radiation exposure.
Animal models for medical countermeasures to radiation exposure.
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DOI：
10.1667/rr1880.1
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发表时间：
2010-04
影响因子：
3.4
通讯作者：
McBride WH
中科院分区：
文献类型：
--
作者：
Williams JP;Brown SL;Georges GE;Hauer-Jensen M;Hill RP;Huser AK;Kirsch DG;Macvittie TJ;Mason KA;Medhora MM;Moulder JE;Okunieff P;Otterson MF;Robbins ME;Smathers JB;McBride WH
自 2001 年 9 月 11 日以来，人们认识到恐怖主义行为可能构成威胁，包括放射性或核攻击。美国各地已经建立了辐射医疗对策中心 (CMCR) 网络；该网络的任务之一是确定和开发可用于在放射事件发生后治疗平民的缓解剂。此类药物的开发需要比较多种来源的数据，并积累符合美国食品和药物管理局（FDA）“动物规则”的信息。鉴于有必要就整个网络中适当的动物模型使用达成共识，以允许跨机构进行比较研究，并确定关键研究并促进 FDA 批准，2008 年初，来自每个 CMCR 的研究人员组织并召开了动物模型研讨会。工作组审议和讨论了可用于评估药物在许多相关组织和器官中的功效的广泛动物模型，包括免疫和造血系统、胃肠道、肺、肾和皮肤。讨论涵盖了最合适的物种和菌株，以及可能影响群体和机构之间差异结果的其他因素。本报告提供了研讨会的调查结果。
Since September 11, 2001, there has been the recognition of a plausible threat from acts of terrorism, including radiological or nuclear attacks. A network of Centers for Medical Countermeasures against Radiation (CMCRs) has been established across the U.S.; one of the missions of this network is to identify and develop mitigating agents that can be used to treat the civilian population after a radiological event. The development of such agents requires comparison of data from many sources and accumulation of information consistent with the “Animal Rule” from the Food and Drug Administration (FDA). Given the necessity for a consensus on appropriate animal model use across the network to allow for comparative studies to be performed across institutions, and to identify pivotal studies and facilitate FDA approval, in early 2008, investigators from each of the CMCRs organized and met for an Animal Models Workshop. Working groups deliberated and discussed the wide range of animal models available for assessing agent efficacy in a number of relevant tissues and organs, including the immune and hematopoietic systems, gastrointestinal tract, lung, kidney and skin. Discussions covered the most appropriate species and strains available as well as other factors that may affect differential findings between groups and institutions. This report provides the workshop findings.