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IGF::OT::IGF:PHARMACOKINETICS AND TOXICOLOGY STUDIES - BUCKPITT LDT,

IGF::OT::IGF：药代动力学和毒理学研究 - BUCKPITT LDT，

基本信息

批准号：
9376318
负责人：
KATHRYN BAUGHMAN
金额：
$ 35.28万
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
起止时间：
2016-06-30 至 2017-06-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9376318
关键词：
Animal Welfare Award Chemistry Client Contractor Contracts Dosage Forms Drug Kinetics Equipment Formulation Heart Diseases Hematological Disease International Laboratory Animals Lung diseases 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 and Toxicology 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 base bench to bedside design experience flexibility good laboratory practice meetings member novel novel therapeutics programs research and development response screening small molecule small molecule therapeutics

项目摘要

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.

根据征求建议书（RFP） NHLBI- hv -10-13， SRI国际公司（SRI）提议作为一个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治疗药物，以支持国家心脏，肺和血液研究所（NHLBI）的科学走向研究转化和治疗（SMARTT）计划，治疗心脏，肺和血液疾病。该合同的总体目标是支持转化研究，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现行良好生产规范（cGMP）生产设施提供服务。非生物制剂和小分子生产设施（PF）将根据其满足请求的能力评估和优先考虑服务请求。SRI对RFP中规定的合同条款不例外，并准备充分响应工作说明书的所有规定。