The MCART Consortium Animal Models Series


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Abstract

The single, overarching goal of the National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Consortium, Medical Countermeasures Against Radiological Threats (MCART), is the development of medical countermeasures (MCM) to treat the key sequelae of the acute radiation syndrome (ARS) and the delayed effects of acute radiation exposure (DEARE). In addition, a parallel goal is to evaluate the toxicity and efficacy of decorporating agents that will reduce the whole-body burden of internalized radionuclides. MCM must be developed within the criteria of the U.S. Food and Drug Administration’s (FDA) “animal rule” (AR) and the subsequent Guidance document for animal models that addresses essential elements to demonstrate efficacy under the animal rule (Crawford 2002; FDA and CBER 2009).The FDA AR underscores the requisite design and conduct of validated animal models as paramount in defining the regulatory pathway to licensure of MCM to treat personnel exposed to potentially lethal doses of radiation that define the major sequelae of the ARS and DEARE.

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