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NIAID Preclinical Development Support: Essential Core Activities

NIAID Preclinical Development Support: Essential Core Activities
NIAID 临床前开发支持：必要的核心活动
批准号：
10207320
负责人：
TIMOTHY FOUTS
金额：
$39.42万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
项目状态：
已结题
起止时间：
2020-08-29 至 2021-08-28
来源：
https://reporter.nih.gov/project-details/10207320
关键词：
AIDS preventionContractorDevelopmentDocumentationHIV vaccineInvestigational DrugsInvestigator-Initiated ResearchModalityNational Institute of Allergy and Infectious DiseasePhasePreclinical TestingProcessProductionSupport Contractsflexibilitypreclinical developmentresearch clinical testingresearch study

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中文摘要
翻译
NIAID临床前开发支持：该合同将为NIAID提供广泛而灵活的非传统、主动和面向发展的能力，当有前途的产品从研究者发起的研究中出现时，为这些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
NIAID Preclinical Development Support: 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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NIAID Preclinical Development Support: Essential Core Activities
NIAID Preclinical Development Support: Essential Core Activities
cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine
cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine
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