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Task X2: Feasibility and PDP support for Rickettsia Prowazekii

Task X2: Feasibility and PDP support for Rickettsia Prowazekii
任务 X2：普氏立克次体的可行性和 PDP 支持
批准号：
8744684
负责人：
NORMAN KNETEMAN
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/8744684
关键词：
BioterrorismClinical ResearchCommunicable DiseasesContractsCyclic GMPDevelopmentDevelopment PlansDrug resistanceEmerging Communicable DiseasesPhaseResearchRickettsia prowazekiiServicesToxicologyUnited States Food and Drug AdministrationVaccinesnovel vaccinespathogenproduct development

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中文摘要
翻译
传染病疫苗和其他生物制品的制造和表征服务(MCS)合同提供各种产品开发服务，包括产品开发规划和可行性评估；I/II期临床研究的产品开发和符合cGMP标准的制造；毒理学研究；技术和设施审计；以及适用于提交美国食品和药物管理局(FDA)的监管支持。这些服务将促进开发和引入新的疫苗和生物制品，以应对生物恐怖主义、抗药性病原体以及新出现和重新出现的传染病的潜在病原体。该合同还规定了挑战材料的制造。
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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TASK A92: Efficacy testing of therapeutics against Hepatitis B in a mouse model
  • 批准号：
    9355867
  • 项目类别：
  • 资助金额：
    $84.28万
  • 财政年份：
    2016
  • 负责人：
    NORMAN KNETEMAN
  • 依托单位：
    KMT HEPATECH INC
Task B12: Comprehensive Virology Panel
  • 批准号：
    8744737
  • 项目类别：
  • 资助金额：
    $58.65万
  • 财政年份：
    2013
  • 负责人：
    NORMAN KNETEMAN
  • 依托单位：
    GEORGETOWN UNIVERSITY
Task A08: In Vitro Characterization Of Antimicrobial Activity
Task A03: In Vitro Screening for Antifungal Activity
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