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NIAID Preclinical Development Support - Production of Research Cell Lines

NIAID Preclinical Development Support - Production of Research Cell Lines
NIAID 临床前开发支持 - 研究细胞系的生产
批准号：
9144292
负责人：
THOMAS VANCOTT
金额：
$7.13万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
项目状态：
已结题
起止时间：
2013-08-23 至 2017-09-14
来源：
https://reporter.nih.gov/project-details/9144292
关键词：
AIDS preventionCell LineClinicalContractorContractsCyclic GMPDataDevelopmentDocumentationElementsGuidelinesHIV vaccineHIV-1Investigational DrugsInvestigational New Drug ApplicationInvestigator-Initiated ResearchModalityNational Institute of Allergy and Infectious DiseasePamphletsPhasePhase I Clinical TrialsPreclinical TestingProcessProductionProtocols documentationResearchResearch PersonnelSafetyTestingVial deviceauthorityflexibilityhuman DNAimmunogenicitymicrobicidepre-clinicalresearch clinical testingresearch studyscale up

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中文摘要
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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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