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
基本信息
- 批准号:10576706
- 负责人:
- 金额:$ 145.31万
- 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:2021-11-17 至 2023-11-16
- 项目状态:已结题
- 来源:
- 关键词:AnimalsAreaBiological TestingChemicalsClinicalClinical ResearchClinical TrialsClinical Trials NetworkContraceptive AgentsContraceptive DevicesContraceptive UsageContraceptive methodsContractorDevelopmentDocumentationDrug FormulationsDrug KineticsEndocrineEnrollmentEvaluationExcretory functionFormulationGoalsInvestigational New Drug ApplicationMetabolismMethodsMissionNational Institute of Child Health and Human DevelopmentOvulationPharmaceutical PreparationsPharmacodynamicsPharmacologic SubstancePhasePlasmaPlayProcessProductionProgram DevelopmentProtocols documentationReportingResearchResearch PersonnelResearch SupportRoleRouteSafetySystemTestingTimeToxic effectToxicologyWomanabsorptionchemical synthesisclinical lotdesigndrug candidatedrug developmentin vitro Assayin vivolot productionmennovel therapeuticspharmacokinetics and pharmacodynamicspopulation healthpre-clinicalpre-clinical researchproduct developmentprogramsrecruitresearch and developmentresearch clinical testingresearch facilitysperm cellsperm functionstability testing
项目摘要
The Contraceptive Development Program (CDP) within Division of Intramural Population Health
Research 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 chemical entities (NCE), 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 assays and in vivo studies,
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 prepared under current Good Manufacturing Practices (cGMP) to 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 trials require stability testing of the clinical formulations. The
Biological Testing Facility plays a critical role in the drug development mission of the CDP.
校内人口健康司的避孕发展方案
NICHD的研究支持开发可以扰乱正常排卵的化合物的研究,
精子生产或精子功能的目的,开发安全,有效和负担得起的
男性或女性的避孕药。生物试验机构(BTF)旨在允许
新化学实体(NCE)、药物制剂、递送系统和装置的快速评价
用于避孕和内分泌活动。BTF提供全面的项目管理,
支持临床前活动的所有阶段的能力,
避孕方法:这些方法包括,但不限于体外试验和体内研究,
血浆和微粒体稳定性研究、吸收、分布、代谢、排泄和
毒性(ADMET)、药代动力学(PK)和药效学(PD)特征分析、动物活动
活性药物成分(API)的研究、生产、工艺和产品
开发、配方、临床批次生产、临床前启动研究和相关任务
导致提交研究性新药(IND)申请。配制的化合物
BTF是根据现行药品生产质量管理规范(cGMP)制备的,
CDP避孕临床试验网络(CCTN)。CCTN调查人员
已制定方案来评估该计划确定为高优先级的候选药物。
生物技术信托基金一直在与化学合成设施和化学技术转让网络的相关国家办事处合作,
与CCTN中的研究者一起开发和测试用于临床的适当制剂,
候选化合物的批次。每种候选药物的下一项临床研究取决于
在及时收到临床批次后,开始招募和入组过程。药物
目前正在进行的临床试验需要临床制剂的稳定性测试。的
生物试验机构在CDP的药物开发使命中发挥着关键作用。
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:
$ 145.31万 - 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:
$ 145.31万 - 项目类别:
BIOLOGICAL TESTING FACILITY – "QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP"
生物测试设施 — “定量结构活性关系”
- 批准号:
10361636 - 财政年份:2021
- 资助金额:
$ 145.31万 - 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:
$ 145.31万 - 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:
$ 145.31万 - 项目类别:
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