BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER
生物测试设施 - 避孕药研发任务单
基本信息
- 批准号:10263608
- 负责人:
- 金额:$ 148.67万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-09-04 至 2022-09-03
- 项目状态:已结题
- 来源:
- 关键词:Animal HusbandryAnimalsAreaBiological AssayBiological TestingChemicalsClinicalClinical ResearchClinical TrialsClinical Trials NetworkContraceptive AgentsContraceptive DevicesContraceptive methodsContractorDevelopmentDocumentationDrug FormulationsEndocrineEnrollmentEvaluationExcretory functionFormulationIn VitroInvestigational DrugsInvestigational New Drug ApplicationMetabolismMethodsMissionNational Institute of Child Health and Human DevelopmentOvulationPharmaceutical PreparationsPharmacologic SubstancePhasePlasmaPlayPreclinical TestingProcessProductionProgram DevelopmentProtocols documentationReportingResearchResearch PersonnelResearch SupportRoleRouteSafetySystemTestingTimeToxic effectToxicologyWomanabsorptionchemical synthesisclinical lotdesigndrug candidatedrug developmenthuman subjectin vitro Assayin vivolot productionmennonhuman primatenovel therapeuticspharmacokinetics and pharmacodynamicspopulation healthpre-clinicalproduct developmentprogramsrecruitresearch and developmentresearch clinical testingsafety studysperm cellsperm functionstability testing
项目摘要
Within the Division of Intramural Population Health Research (DIPHR), the Contraceptive
Development Program (CDP) at NICHD supports research to develop 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 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 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 are, or will be, tested in non-human primates. NICHD maintains a
colony of non-human primates for the purpose of evaluating potential contraceptive agents prior to
trials in human subjects. 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 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
next clinical study for each candidate drug is dependent on timely receipt of clinical batches to
begin the process of recruitment and enrollment. Drugs that are currently in ongoing clinical
of the clinical formulations. 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(DIPHR)内,避孕
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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TOUFAN PARMAN其他文献
TOUFAN PARMAN的其他文献
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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:
$ 148.67万 - 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:
$ 148.67万 - 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:
$ 148.67万 - 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:
$ 148.67万 - 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:
$ 148.67万 - 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:
$ 148.67万 - 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:
$ 148.67万 - 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:
$ 148.67万 - 项目类别:
BIOLOGICAL TESTING FACILITY - CHARACTERIZATION OF POTENTIAL OVULATION INHIBITORS
生物测试设施 - 潜在排卵抑制剂的表征
- 批准号:
10021077 - 财政年份:2019
- 资助金额:
$ 148.67万 - 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:
$ 148.67万 - 项目类别:
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