NIAID PRECLINICAL DEVELOPMENT SUPPORT - TOXICITY TESTING FOR CH505 T/F GP120 PROTEIN
NIAID PRECLINICAL DEVELOPMENT SUPPORT - TOXICITY TESTING FOR CH505 T/F GP120 PROTEIN
批准号:
8939176
负责人:
NANCY LIN
金额:
$65.75万
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:
2014-09-26 至 2017-08-31
关键词:
AIDS preventionContractorContractsDataDevelopmentDocumentationGuidelinesHIV Envelope Protein gp120HIV vaccineInvestigational DrugsInvestigational New Drug ApplicationInvestigator-Initiated ResearchModalityNational Institute of Allergy and Infectious DiseasePamphletsPhasePreclinical TestingProcessProductionProteinsProtocols documentationResearch PersonnelSafetyTestingToxicity Testsauthorityflexibilityimmunogenicitymicrobicidepre-clinicalresearch clinical testingresearch study
中文摘要
该合同将为NIAID提供广泛而灵活的非传统、前瞻性和发展导向的能力,当这些产品从研究者发起的研究中出现时,为有前途的产品提供临床前开发支持。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。承包商应协助NIAID工作人员提供小规模生产、临床前测试和文件所需的所有支持,以提交I、II和III期临床测试的研究新药(IND)
英文摘要
This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing
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依托单位:
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财政年份:2008
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海外基金