ANIMAL MODEL DEVELOPMENT AND INITIAL EFFICACY TESTING

动物模型开发和初步疗效测试

• 批准号: 10391297
• 负责人: POLLY CHANG
• 金额: $ 118.81万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2021-12-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10391297
• 关键词: Award; Clinical; Contract Services; Contracts; Documentation; Evaluation; Formulation; Human; Medical Licensure; National Institute of Allergy and Infectious Disease; Nuclear; Pharmacology Study; Radiation; Radiation Injuries; Radiology Specialty; Research; Safety; Services; Strategic Planning; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; animal efficacy; animal model development; authority; efficacy study; efficacy testing; good laboratory practice; medical countermeasure; product development; research and development; stability testing

The Department of Health and Human Services has assigned the NIH the responsibility to identify, characterize, and develop new medical countermeasures (MCM) against radiological or nuclear threats. As part of the “NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats”, the NIAID awarded the Medical Countermeasures against Radiological Threats: Product Development Support Services contract to provide support services for products that may have the potential to become radiation or nuclear medical countermeasures. This contract is tasked with bringing these potential countermeasures to a point at which they can 1) be approved or licensed by the U.S. Food and Drug Administration (FDA) or 2) transition to the Biomedical Advanced Research and Development Authority (BARDA). When approved, these MCMs could be acquired by the Strategic National Stockpile.

卫生与公众服务部已责成国家卫生研究院负责确定、鉴定和开发新的医疗对策（MCM），以应对放射性或核威胁。作为“美国国立卫生研究院应对辐射和核威胁的医疗对策战略计划和研究议程”的一部分，美国国立卫生研究院授予了《应对辐射威胁的医疗对策：产品开发支持服务》合同，为可能成为辐射或核医疗对策的产品提供支持服务。该合同的任务是使这些潜在的对策达到1)获得美国食品和药物管理局（FDA）的批准或许可，或2)过渡到生物医学高级研究与发展管理局（BARDA）。经批准后，这些mcm可由国家战略储备获得。