Task X2: Feasibility and PDP support for RSV vaccines
Task X2: Feasibility and PDP support for RSV vaccines
批准号:
8744682
负责人:
NORMAN KNETEMAN
金额:
$9.09万
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-09-17 至 2016-09-15
关键词:
BioterrorismClinical ResearchCommunicable DiseasesContractsCyclic GMPDevelopmentDevelopment PlansDrug resistanceEmerging Communicable DiseasesPhaseRespiratory Syncytial Virus VaccinesServicesToxicologyUnited States Food and Drug AdministrationVaccine ResearchVaccinesnovel vaccinespathogenproduct development
中文摘要
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英文摘要
The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services spanning product development planning and feasibility assessments; product development and cGMP compliant manufacture for Phase I/II clinical studies; toxicology studies; technical and facility audits; and regulatory support appropriate for submission to the U.S. Food and Drug Administration (FDA). These services will facilitate the development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases. This contract also provides for manufacture of challenge material.
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依托单位:
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海外基金