BIOLOGICAL TESTING FACILITY - CHARACTERIZATION OF POTENTIAL OVULATION INHIBITORS
生物测试设施 - 潜在排卵抑制剂的表征
基本信息
- 批准号:10021077
- 负责人:
- 金额:$ 75万
- 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
- 起止时间:2019-09-27 至 2020-09-26
- 项目状态:已结题
- 来源:
- 关键词:AnimalsBiological AssayBiological TestingChemical StructureClinicalClinical TrialsClinical Trials NetworkContraceptive AgentsContraceptive DevicesContraceptive methodsContractsDevelopmentDrug FormulationsDrug KineticsEndocrineEvaluationExcretory functionFormulationIn VitroInvestigational New Drug ApplicationMeasuresMetabolismMethodsMicrosomesMissionNational Institute of Child Health and Human DevelopmentOvulationPharmacodynamicsPharmacologic SubstancePhasePlasmaPlayProcessProductionResearchResearch PersonnelResearch SupportRoleSafetySystemTestingToxic effectToxicologyWomanabsorptionchemical synthesisclinical lotdesigndrug developmentin vitro Assayin vivoinhibitor/antagonistlot productionmennovel therapeuticspharmacokinetics and pharmacodynamicspre-clinicalproduct developmentresearch clinical testingsperm cellsperm function
项目摘要
Background:
The Contraception Research Branch (CRB) within NICHD supports research to develop compounds that can disrupt normal ovulation, sperm production or sperm function so that safe and effective contraceptives can be developed for men or women. The Biological Testing Facility (BTF) is designed to permit 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 to in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion (ADME), toxicity, 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. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The BTF has been working with the Contracting Officer’s Representatives (CORs) for the Chemical Synthesis Facility and the Contraceptive Clinical Trials Network (CCTN) and with the investigators in the CCTN to develop and test the appropriate formulations for clinical batches of the candidate compounds. The BTF plays a critical role in the drug development mission of the CRB.
Scope and Objectives:
Preclinical activities of potential contraceptive products using either in-house or appropriate subcontract facilities as described in the Background including but not limited to the following:
1)Characterization of compounds including confirmation of chemical structure and development of appropriateformulations suitable for in vitro and in vivo studies. 2) Biologic testing of compounds and/or active pharmaceutical ingredients (API) by in vivo and in vitro assays to measure microsome stability, PK, PD, ADME, efficacy, safety and toxicology in appropriate vehicles and appropriate compound concentrations. These studies would support early characterization of compounds that would support eventual testing in clinical trials and ultimately toward filing a New Drug Application (NDA) for approval of a new method of achieving contraception.
背景:
NICHD 的避孕研究部门 (CRB) 支持研究开发可以扰乱正常排卵、精子生成或精子功能的化合物,以便为男性或女性开发安全有效的避孕药具。生物测试设施 (BTF) 旨在快速评估新的物质成分、药物配方、输送系统以及避孕和内分泌活性装置。 BTF 提供整体项目管理和支持新避孕方法开发的临床前活动所有阶段的能力:这些包括但不限于体外和体内测定、血浆和微粒体稳定性研究、吸收、分布、代谢、排泄 (ADME)、毒性、药代动力学 (PK) 和药效 (PD) 分析、动物活动和 研究、活性药物成分 (API) 的制造、工艺和产品开发、配方、临床批量生产、临床前研究以及导致提交研究性新药 (IND) 申请的相关任务。 BTF 有能力根据现行良好生产规范 (cGMP) 制备化合物以进行临床评估。 BTF 一直与化学合成设施和避孕临床试验网络 (CCTN) 的合同官员代表 (COR) 以及 CCTN 的研究人员合作,开发和测试候选化合物临床批次的适当配方。 BTF 在 CRB 的药物开发任务中发挥着关键作用。
范围和目标:
使用背景中所述的内部或适当的分包设施进行潜在避孕产品的临床前活动,包括但不限于以下内容:
1) 化合物的表征,包括化学结构的确认和适合体外和体内研究的适当制剂的开发。 2) 通过体内和体外测定对化合物和/或活性药物成分(API)进行生物学测试,以在适当的载体和适当的化合物浓度下测量微粒体稳定性、PK、PD、ADME、功效、安全性和毒理学。这些研究将支持化合物的早期表征,从而支持临床试验中的最终测试,并最终提交新药申请(NDA)以批准实现避孕的新方法。
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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{{ truncateString('TOUFAN PARMAN', 18)}}的其他基金
BIOLOGICAL TESTING FACILITY - "RESEARCH AND DEVELOPMENT OF PRECLINICAL CONTRACEPTIVES".
生物测试设施 - “临床前避孕药的研究和开发”。
- 批准号:
10352181 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - ADMINISTRATIVE / MANAGEMENT / DATABASE TASK ORDER
生物检测设施 - 行政/管理/数据库任务单
- 批准号:
10927162 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER
生物测试设施 - 避孕药研发任务单
- 批准号:
10390264 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - "RESEARCH AND DEVELOPMENT OF PRECLINICAL CONTRACEPTIVES".
生物测试设施 - “临床前避孕药的研究和开发”。
- 批准号:
10183638 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER
生物测试设施 - 避孕药研发任务单
- 批准号:
10263608 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - "CONTRACEPTIVE DRUG AND INTRAVAGINAL CONTRACEPTIVE DEVICE EVALUATION"
生物测试设施 - “避孕药物和阴道内避孕器具评估”
- 批准号:
10271538 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - ADMINISTRATIVE / MANAGEMENT / DATABASE TASK ORDER
生物检测设施 - 行政/管理/数据库任务单
- 批准号:
10263606 - 财政年份:2020
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - RESEARCH AND DEVELOPMENT OF PRECLINICAL CONTRACEPTIVES
生物测试设施 - 临床前避孕药的研究和开发
- 批准号:
10013411 - 财政年份:2019
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - FORMULATION DEVELOPMENT CLINICAL MANUFACTURING AND STABILITY TESTING
生物测试设施 - 制剂开发、临床制造和稳定性测试
- 批准号:
10266724 - 财政年份:2019
- 资助金额:
$ 75万 - 项目类别:
BIOLOGICAL TESTING FACILITY - FORMULATION DEVELOPMENT CLINICAL MANUFACTURING AND STABILITY TESTING
生物测试设施 - 制剂开发、临床制造和稳定性测试
- 批准号:
10013413 - 财政年份:2019
- 资助金额:
$ 75万 - 项目类别:
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