A Novel Nanoparticle Platelet Analogue for Radiation-Induced Thrombocytopenia
A Novel Nanoparticle Platelet Analogue for Radiation-Induced Thrombocytopenia
批准号:
9123478
负责人:
JUN CHEN
金额:
$199.81万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2014
资助国家:
美国
项目状态:
已结题
起止时间:
2014-09-01 至 2016-08-31
关键词:
Advanced DevelopmentAreaBiological ProductsBlood PlateletsContractsDataGoalsHemorrhageHemostatic AgentsInvestigational DrugsInvestigational New Drug ApplicationLeadLicensureMedicalMusRadiationRadiation InjuriesRecoverySafetySeriesThrombocytopeniaTranslational Researchanalogdrug candidatenanoparticlenonhuman primatenovelpreventproduct developmentresearch and developmentresearch studysafety study
中文摘要
该合同将推进主要候选药物或生物制品的开发,主要通过减轻和/或治疗放射诱导的血小板减少症来增加生存期,进行转化研究和开发,并提供额外的信息和数据,以支持提交研究新药(IND)申请和最终的FDA批准或许可。该合同为一种主要医疗对策制定了明确的产品开发路径,其中包括将根据合同进行的自主研发研究。
英文摘要
The contract will advance the development of lead candidate drugs or biological products that increase survival primarily by mitigating and/or treating radiation-induced thrombocytopenia, conduct translational research and development, and provide additional information and data that support submission of an Investigational New Drug (IND) application and eventual FDA approval or licensure. The contract has a well-defined product development path for a lead medical countermeasure that includes IND-enabling studies to be performed under the contract.
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A Novel Nanoparticle Platelet Analogue for Radiation-Induced Thrombocytopenia
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A Novel Nanoparticle Platelet Analogue for Radiation-Induced Thrombocytopenia
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