Reproductive Toxicology Studies of Elsulfavirin with Toxicokinetics in Rats, and to Support the Development of Mitochondrial Toxicity Assays and Sample Analysis for Mitochondrial Toxicity Assessment
Reproductive Toxicology Studies of Elsulfavirin with Toxicokinetics in Rats, and to Support the Development of Mitochondrial Toxicity Assays and Sample Analysis for Mitochondrial Toxicity Assessment
批准号:
9983283
负责人:
JON MIRSALIS
金额:
$116.28万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-07-15 至 2020-10-14
关键词:
Acquired Immunodeficiency SyndromeBiological AssayCell LineContractsDevelopmentDevelopment PlansDrug ExposureEvaluationFormulationHIVHIV InfectionsHIV therapyHalf-LifeIn VitroInterventionLiquid substanceMitochondriaNational Institute of Allergy and Infectious DiseasePharmacologic SubstancePharmacology and ToxicologyProdrugsRattusResearch PersonnelReverse Transcriptase InhibitorsSamplingServicesSystemTherapeutic AgentsToxic effectToxicokineticsToxicologyUnited States Dept. of Health and Human ServicesUnited States National Institutes of Healthclinical investigationco-infectiondrug developmentmicrobicidepreventreproductivesexual HIV transmissiontransmission processtwo-dimensional
中文摘要
美国国家过敏症和传染病研究所(NIAID)、美国国立卫生研究院(NIH)、卫生与公众服务部(DHHS)的艾滋病司(DAIDS)持有一系列合同,以支持开发(1)艾滋病毒感染及其并发症和合并感染的治疗方法,以及(2)预防艾滋病毒性传播的杀微生物剂。根据该合同提供的服务有助于学术机构和小型制药公司的研究人员填补其药物开发计划中的具体空白,因为他们将其产品推向艾滋病毒感染治疗和预防艾滋病毒传播干预措施的临床研究。活动将包括开发潜在治疗剂和杀微生物剂的配方。此外,还将进行研究,以评估潜在治疗剂和杀微生物剂的药理学和毒理学。
英文摘要
The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), maintains a portfolio of contracts to support the development of (1) therapies for HIV infection and its complications and coinfections, and (2) microbicides for preventing the sexual transmission of HIV. Services provided under this contract assist investigators in academic settings and small pharmaceutical firms in filling specific gaps in their drug development plan as they advance their product towards clinical investigation of therapies for HIV infection and interventions to prevent HIV transmission. Activities will include the development of formulations of potential therapeutic agents and microbicides. In addition studies will be conducted to assess the pharmacology and toxicology of potential therapeutic agents and microbicides.
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会议论文
Task Order D14: Preclinical, Microbiological, Safety, Toxicology, and Pharmacokinetic Services
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批准号:10901158
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项目类别:
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资助金额:$475.03万
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财政年份:2023
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负责人:JON MIRSALIS
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依托单位:
Task C19: Recertification for clinical use of GMP Product
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批准号:10683807
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项目类别:
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资助金额:$15.77万
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财政年份:2022
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负责人:JON MIRSALIS
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依托单位:
TASK A06: DEVELOPMENT OF A PRECLINICAL NEPHROTOXICITY SCREENING PLAN
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批准号:10613209
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项目类别:
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资助金额:$4.98万
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财政年份:2022
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负责人:JON MIRSALIS
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依托单位:
Task C15: APP SYNTHESIS OF YELLOW FEVER COMPOUNDS
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批准号:10613201
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项目类别:
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资助金额:$12.24万
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财政年份:2022
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负责人:JON MIRSALIS
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依托单位:
Task Order D-13 PRE-CLINICAL MICROBIOLOGICAL, SAFETY, TOXICOLOGY, AND PHARMACOKINETIC SERVICES
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批准号:10895064
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项目类别:
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资助金额:$227.2万
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财政年份:2022
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负责人:JON MIRSALIS
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依托单位:
Task A03: Nonclinical Service Training
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批准号:10448654
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项目类别:
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资助金额:$7.85万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
Task B19: Synthesis of LpxC Inhibitors with Improved Physicochemical Properties
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批准号:10382938
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项目类别:
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资助金额:$25.71万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
TISSUE CROSS-REACTIVITY STUDY OF A HUMAN ANTIBODY
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批准号:10474740
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项目类别:
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资助金额:$10.75万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
Task A5: Update of Generic Product Development Plan
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批准号:10454571
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项目类别:
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资助金额:$4.0万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
Preclinical Services for HIV Therapeutics: QA/QC Plan and Task Order Initiation Meeting
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批准号:10397446
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项目类别:
-
资助金额:$2.94万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
Task A03: Nonclinical Service Training
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批准号:10579805
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项目类别:
-
资助金额:$3.21万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
TASK C12: INVESTIGATION AND OPTIMIZATION OF PRECLINICAL THERAPEUTIC FORMULATIONS AGAINST RESISTANT BACTERIA
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批准号:10393342
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项目类别:
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资助金额:$23.76万
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财政年份:2021
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负责人:JON MIRSALIS
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依托单位:
Task C08: Manufacturing of a colon-delivery formulation platform of metronidazole for treating Clostridium difficile infection
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批准号:10254515
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项目类别:
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资助金额:$157.54万
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财政年份:2020
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负责人:JON MIRSALIS
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依托单位:
Formulation Development and Clinical Manufacturing: Manufacture of TLC-ART101 Bulk Product for Clinical Trials
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批准号:10449189
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项目类别:
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资助金额:$29.48万
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财政年份:2020
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负责人:JON MIRSALIS
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依托单位:
Task D06: Nonclinical Microbiological, Safety, Toxicology, and Pharmacokinetic Services
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批准号:10414864
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项目类别:
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资助金额:$28.29万
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财政年份:2020
-
负责人:JON MIRSALIS
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依托单位:
Task D05: Nonclinical Services for the Development of Interventional Agents for Infectious Diseases
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批准号:10246566
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项目类别:
-
资助金额:$40.0万
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财政年份:2020
-
负责人:JON MIRSALIS
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依托单位:
Task C08: Manufacturing of a colon-delivery formulation platform of metronidazole for treating Clostridium difficile infection
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批准号:10361172
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项目类别:
-
资助金额:$11.51万
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财政年份:2020
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负责人:JON MIRSALIS
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依托单位:
Task B11: Polymorph characterization and salt screening of a potential therapeutic for gram negative bacteria
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批准号:10115304
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项目类别:
-
资助金额:$4.02万
-
财政年份:2020
-
负责人:JON MIRSALIS
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依托单位:
Formulation Development and Clinical Manufacturing: Manufacture of TLC-ART101 Bulk Product for Clinical Trials
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批准号:10215314
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项目类别:
-
资助金额:$78.56万
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财政年份:2020
-
负责人:JON MIRSALIS
-
依托单位:
Task D06: Nonclinical Microbiological, Safety, Toxicology, and Pharmacokinetic Services
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批准号:10414863
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项目类别:
-
资助金额:$12.73万
-
财政年份:2020
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负责人:JON MIRSALIS
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依托单位:
海外基金