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Task X2: Feasibility and PDP support for Malaria Vaccines

Task X2: Feasibility and PDP support for Malaria Vaccines
任务 X2：疟疾疫苗的可行性和 PDP 支持
批准号：
8845037
负责人：
JAMES RICHARDSON
金额：
$9.09万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
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
来源：
https://reporter.nih.gov/project-details/8845037
关键词：
BioterrorismClinical ResearchCommunicable DiseasesContractsCyclic GMPDevelopmentDevelopment PlansDrug resistanceEmerging Communicable DiseasesMalaria VaccinesPhasePlasmodium falciparumResearchServicesToxicologyUnited States Food and Drug AdministrationVaccinesnovel vaccinespathogenproduct development

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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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