BIOLOGICAL TESTING FACILITY – "QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP"
生物测试设施 — “定量结构活性关系”
基本信息
- 批准号:10361636
- 负责人:
- 金额:$ 12.57万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-01-07 至 2022-01-06
- 项目状态:已结题
- 来源:
- 关键词:AffinityAndrogensAnimalsBindingBiological AssayBiological TestingClinicalClinical Trials NetworkComputer ModelsContraceptive AgentsContraceptive DevicesContraceptive methodsDataDevelopmentDrug FormulationsEndocrineEstrogensEvaluationExcretory functionFormulationIn VitroInvestigational New Drug ApplicationLigandsMeasuresMetabolismMissionModelingNational Institute of Child Health and Human DevelopmentOvulationPharmacologic SubstancePhasePlasmaPlayProcessProductionProgesteroneProgram DevelopmentProtocols documentationQuantitative Structure-Activity RelationshipResearchResearch PersonnelResearch SupportRoleSteroid ReceptorsStructureStructure-Activity RelationshipSystemTechniquesTestingToxic effectWomanabsorptionbasechemical synthesischeminformaticsclinical lotdesigndrug candidatedrug developmentin silicoin vivolot productionmenpharmacokinetics and pharmacodynamicspopulation healthpre-clinicalpredictive modelingproduct developmentprogramsresearch and developmentresearch clinical testingsperm cellsperm functionsteroid analog
项目摘要
Within the Division of Intramural Population Health Research (DIPHR), the Contraceptive
Development Program (CDP) at NICHD supports research and development of compounds that
can disrupt normal ovulation, sperm production or sperm function for the purpose of developing
safe, effective and affordable contraceptives for men or women. The Biological Testing Facility
(BTF) is designed to allow discovery and rapid evaluation of new compositions-of-matter, drug
formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF
provides overall project management and the capabilities to support all phases of preclinical
activities pursuant to development of new contraceptive methods: these include, but are not limited
in silico/computational modeling, to in vitro and in vivo assays, plasma and microsomal stability
studies, absorption, distribution, metabolism, excretion and toxicity (ADMET), pharmacokinetic
(PK) and pharmacodynamic (PD) profiling, animal activities and studies, manufacture of active
pharmaceutical ingredients (APIs), process and product development, formulation, clinical lot
production, preclinical enabling studies and associated tasks leading to the filing of investigational
new drug (IND) applications. Compounds formulated by the BTF that are prepared under current
Good Manufacturing Practices (cGMP) will allow clinical evaluation in the CDP Contraceptive
Clinical Trials Network (CCTN). The CCTN investigators have develop protocols to evaluate the
drug candidates identified as high priority by the Program. The BTF has been working with the
CORs for the Chemical Synthesis Facility (CSF) and the CCTN and with the investigators in the
CCTN to develop and test the appropriate formulations for clinical batches of the candidate
compounds. The Biological Testing Facility plays a critical role in the drug development mission
of the CDP.
在校内人口健康研究司内,
NICHD的开发计划(CDP)支持化合物的研究和开发,
可以破坏正常排卵,精子生产或精子功能,以促进发育
安全、有效和负担得起的男女避孕药具。生物试验机构
(BTF)旨在发现和快速评估新的物质组合物,药物
用于避孕和内分泌活性的制剂、递送系统和装置。BTF
提供全面的项目管理和支持临床前所有阶段的能力
为开发新的避孕方法而开展的活动:包括但不限于
体外和体内试验、血浆和微粒体稳定性的计算机模拟/计算建模
研究、吸收、分布、代谢、排泄和毒性(ADMET)、药代动力学
(PK)和药效学(PD)分析,动物活动和研究,活性药物的生产
药物成分(API)、工艺和产品开发、配方、临床批次
生产、临床前使能研究和相关任务,导致提交研究性
新药申请(IND)由BTF配制的化合物在当前条件下制备,
药品生产质量管理规范(cGMP)将允许在CDP避孕药中进行临床评价。
临床试验网络(CCTN)。CCTN研究人员已经制定了方案来评估
被该计划确定为高度优先的候选药物。BTF一直在与
化学合成设施(CSF)和CCTN的COR以及研究人员在
CCTN开发和检测候选药物临床批次的适当制剂
化合物.生物试验机构在药物开发使命中发挥着关键作用
的CDP。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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DEBORAH BUNIN其他文献
DEBORAH BUNIN的其他文献
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{{ truncateString('DEBORAH BUNIN', 18)}}的其他基金
BIOLOGICAL TESTING FACILITY - DISCOVERY, CLINICAL FORMULATION, AND MANUFACTURE OF CONTRACEPTIVES
生物测试设施 - 避孕药具的发现、临床配方和制造
- 批准号:
10923031 - 财政年份:2023
- 资助金额:
$ 12.57万 - 项目类别:
BIOLOGICAL TESTING FACILITY (BTF) - DEVELOPMENT OF CONTRACEPTIVE PRODUCTS INTENDED FOR NON-SYSTEMIC DELIVERY
生物测试设施 (BTF) - 开发用于非系统分娩的避孕产品
- 批准号:
10936055 - 财政年份:2023
- 资助金额:
$ 12.57万 - 项目类别:
BIOLOGICAL TESTING FACILITY - RESEARCH, OPTIMIZATION, AND DEVELOPMENT OF CONTRACEPTIVE
生物测试设施 - 避孕药具的研究、优化和开发
- 批准号:
10576706 - 财政年份:2021
- 资助金额:
$ 12.57万 - 项目类别:
BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE TARGET APPLICATION
生物测试设施 - 避孕目标应用
- 批准号:
10788177 - 财政年份:2021
- 资助金额:
$ 12.57万 - 项目类别:
BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE TARGET APPLICATION
生物测试设施 - 避孕目标应用
- 批准号:
10576708 - 财政年份:2021
- 资助金额:
$ 12.57万 - 项目类别:
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