IGF::OT::IGF 任务顺序-猫眼课题宝

IGF::OT::IGF 任务顺序

批准号：

10910830

负责人：

CAROL E GREEN

金额：

$8.15万

依托单位：

SRI INTERNATIONAL

依托单位国家：

美国

项目类别：

财政年份：

2016

资助国家：

美国

项目状态：

已结题

起止时间：

2016-09-13 至 2024-09-12

来源：

https://reporter.nih.gov/project-details/10910830

关键词：

Animal Welfare Award Biological Products Chemistry Client Contractor Contracts Dosage Forms Equipment Formulation Good Manufacturing Process Heart Diseases Hematological Disease International Laboratory Animals Lung diseases Modernization National Heart, Lung, and Blood Institute National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Drug Abuse National Institute of Mental Health National Institute of Neurological Disorders and Stroke Office for Human Research Protections Pharmacologic Substance Pharmacology Principal Investigator Production Qualifying Regulation Request for Proposals Resources Science Scientist Services Testing Toxicology Translational Research United States Food and Drug Administration United States National Institutes of Health Work bench to bedside design experience flexibility good laboratory practice manufacture member novel novel therapeutics operation programs research and development response screening small molecule small molecule therapeutics

项目摘要

项目成果

CAROL E GREEN的其他基金

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中文摘要

翻译

作为对征求建议书(RFP)NHLBI-HV-10-13的响应，SRI国际(SRI)建议作为灵活和响应迅速的资源承包商，生产和测试新型非生物和小分子疗法，以支持国家心肺和血液研究所(NHLBI)的科学转向研究翻译和治疗(SMART)计划，以治疗心、肺和血液疾病。该合同的总体目标是支持翻译研究，并作为美国食品和药物管理局(FDA)定义的非生物和小分子治疗产品的当前良好制造规范(CGMP)生产设施提供服务。非生物和小分子生产设施(PF)将根据其满足服务请求的能力对服务请求进行评估和优先排序。SRI对招标书中所述的合同条款没有任何异议，并准备充分回应工作说明的所有规定。

英文摘要

In response to Request for Proposal (RFP) NHLBI-HV-10-13, SRI International (SRI) proposes to act as a flexible and responsive resource contractor for the production and testing of novel non-biologic and small molecule therapeutics in support of the National Heart, Lung, and Blood Institute's (NHLBI) Science Moving towards Research Translation and Therapy (SMARTT) program to treat heart, lung, and blood diseases. The overall objective of this contract is to support translational research and provide services as a U.S. Food and Drug Administration (FDA)- defined current good manufacturing practice (cGMP) production facility for non-biological and small molecule therapy products. The Non-Biologics and Small Molecules Production Facility (PF) will evaluate and prioritize requests for service based on its ability to fulfill the requests. SRI takes no exceptions to the contract terms stated in the RFP and is prepared to be fully responsive to all the provisions of the statement of work.

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