IGF::OT::IGF:PHARMACOKINETICS AND TOXICOLOGY STUDIES - BUCKPITT LDT,
IGF::OT::IGF:PHARMACOKINETICS AND TOXICOLOGY STUDIES - BUCKPITT LDT,
批准号:
9376318
负责人:
KATHRYN BAUGHMAN
金额:
$35.28万
依托单位:
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:
2016-06-30 至 2017-06-29
关键词:
Animal WelfareAwardChemistryClientContractorContractsDosage FormsDrug KineticsEquipmentFormulationHeart DiseasesHematological DiseaseInternationalLaboratory AnimalsLung diseasesNational Heart, Lung, and Blood InstituteNational Institute of Allergy and Infectious DiseaseNational Institute of Child Health and Human DevelopmentNational Institute of Diabetes and Digestive and Kidney DiseasesNational Institute of Drug AbuseNational Institute of Mental HealthNational Institute of Neurological Disorders and StrokeOffice for Human Research ProtectionsPharmacologic SubstancePharmacology and ToxicologyPrincipal InvestigatorProductionQualifyingRegulationRequest for ProposalsResourcesScienceScientistServicesTestingToxicologyTranslational ResearchUnited States Food and Drug AdministrationUnited States National Institutes of HealthWorkbasebench to bedsidedesignexperienceflexibilitygood laboratory practicemeetingsmembernovelnovel therapeuticsprogramsresearch and developmentresponsescreeningsmall moleculesmall molecule therapeutics
中文摘要
为了响应征求建议书(RFP)NHLBI-HV-10-13,SRI International(SRI)提议作为一个灵活和响应的资源承包商,用于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)的科学转向研究转化和治疗(SMARTT)计划,以治疗心脏,肺和血液疾病。该合同的总体目标是支持转化研究,并作为美国食品药品监督管理局(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)将根据其满足服务请求的能力对服务请求进行评估和优先排序。SRI对RFP中规定的合同条款没有任何例外,并准备充分响应工作说明书的所有规定。
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Preclinical Development Services for AIDS Therapeutics
-
批准号:9932231
-
项目类别:
-
资助金额:$24.53万
-
财政年份:2019
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - MAINTENANCE OF EXISTING NON-HUMAN PRIMATE COLONY
-
批准号:9922696
-
项目类别:
-
资助金额:$31.59万
-
财政年份:2018
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - MAINTENANCE OF EXISTING NON-HUMAN PRIMATE COLONY
-
批准号:9774893
-
项目类别:
-
资助金额:$104.2万
-
财政年份:2018
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF:CONTRACT ADMINISTRATION - PERIOD OF PERFORMANCE 9/13/2016-9/12/2017
-
批准号:9374281
-
项目类别:
-
资助金额:$3.24万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF SMARTT PHARMACOLOGY AND TOXICOLOGY CENTER (PTC); BASE PERIOD; FY16; AMT $1,653,316; CAN 8470205
-
批准号:9444398
-
项目类别:
-
资助金额:$140.64万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF:PHARMACOKINETICS AND TOXICOLOGY STUDIES:IND - ENABLING STUDIES - WAGNER LTD 9/15/16-9/14/17
-
批准号:9594389
-
项目类别:
-
资助金额:$19.41万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF SMARTT PHARMACOLOGY AND TOXICOLOGY CENTER (PTC); BASE PERIOD; FY16; AMT $1,653,316; CAN 8470205
-
批准号:9365901
-
项目类别:
-
资助金额:$165.33万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF:PHARMACOKINETICS AND TOXICOLOGY STUDIES:IND - ENABLING STUDIES - WAGNER LTD 9/15/16-9/14/17
-
批准号:9376315
-
项目类别:
-
资助金额:$141.53万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - CLINICAL DEVELOPMENT AND FORMULATION OPTIMIZATION OF NEW PRODUCTS OR DEVICES FOR CONTRACEPTIVE METHODS
-
批准号:9360644
-
项目类别:
-
资助金额:$139.79万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF INITIAL ADMINISTRATIVE CHARGES TO#1 PRE-CLIN TOX STUDY OF DRUG DEV FOR CANCER PATIENTS HHSN261201600017I DTP-16-043 TPB
-
批准号:9362795
-
项目类别:
-
资助金额:$0.15万
-
财政年份:2016
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - MANAGEMENT, ADMINISTRATION AND DATABASE
-
批准号:9497596
-
项目类别:
-
资助金额:$68.27万
-
财政年份:2015
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - FORMULATION, SUPPLY, AND STABILITY TESTING OF CONTRACEPTIVE DRUG CANDIDATES FOR CLINICAL TESTING
-
批准号:9147745
-
项目类别:
-
资助金额:$174.5万
-
财政年份:2015
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - PRECLINICAL DEVELOPMENT OF CONTRACEPTIVES
-
批准号:9147746
-
项目类别:
-
资助金额:$72.07万
-
财政年份:2015
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - MAINTENANCE OF EXISTING NON-HUMAN PRIMATE COLONY
-
批准号:9556091
-
项目类别:
-
资助金额:$89.06万
-
财政年份:2015
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - MANAGEMENT, ADMINISTRATION AND DATABASE
-
批准号:9145314
-
项目类别:
-
资助金额:$32.17万
-
财政年份:2015
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
BIOLOGICAL TESTING FACILITY - MANAGEMENT, ADMINISTRATION AND DATABASE
-
批准号:10018598
-
项目类别:
-
资助金额:$30.12万
-
财政年份:2015
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF GENERAL ADMINISTRATIVE AND TECHNICAL SUPPORT
-
批准号:8938938
-
项目类别:
-
资助金额:$24.12万
-
财政年份:2014
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF GENERAL ADMINISTRATIVE AND TECHNICAL SUPPORT
-
批准号:9089782
-
项目类别:
-
资助金额:$24.2万
-
财政年份:2014
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF "Rodent Pharmacokinetic and Brain Level Determination"
-
批准号:8940315
-
项目类别:
-
资助金额:$15.08万
-
财政年份:2014
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
IGF::OT::IGF FORMULATION DEVELOPMENT AND EVALUATION STUDIES OF METHOTREXATE, NEVIRAPINE, SUTEZOLID, LEVOFLOXACIN, AND RUXOLITNIB
-
批准号:8938940
-
项目类别:
-
资助金额:$12.24万
-
财政年份:2014
-
负责人:KATHRYN BAUGHMAN
-
依托单位:
海外基金