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Task V7: Clinical and NHP Sample Testing for SARS-CoV-2 Biological Product Candidates

Task V7: Clinical and NHP Sample Testing for SARS-CoV-2 Biological Product Candidates
任务 V7：SARS-CoV-2 候选生物制品的临床和 NHP 样品检测
批准号：
10329730
负责人：
THOMAS RUDGE
金额：
$17.23万
依托单位：
BATTELLE CENTERS/PUB HLTH RES & EVALUATN
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：
2020-08-27 至 2022-08-26
来源：
https://reporter.nih.gov/project-details/10329730
关键词：
2019-nCoVBiologicalBiological ProductsBioterrorismCOVID-19COVID-19 testingCOVID-19 therapeuticsClinicalCommunicable DiseasesContractsDevelopmentEmerging Communicable DiseasesFeasibility StudiesInvestigational New Drug ApplicationLicensingSamplingServicesVaccinesevaluation/testingproduct developmenttesting servicestherapeutic development

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中文摘要
翻译
传染病疫苗和其他生物制品评估和测试服务(ETS)合同提供从早期可行性研究到提交生物许可证申请(BLA)和/或研究新药(IND)申请所需的各种产品开发服务。这些服务将促进开发和引入新的生物制品(由CBER管理)，以对抗生物恐怖主义和新出现和重新出现的传染病的潜在病原体。
英文摘要
The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. These services will facilitate the development and introduction of new biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.
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