BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER
BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER
批准号:
10390264
负责人:
TOUFAN PARMAN
金额:
$58.76万
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
项目状态:
已结题
起止时间:
2020-09-04 至 2022-09-03
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
中文摘要
在校内人口健康研究司内,
NICHD的开发计划(CDP)支持研究开发可以破坏正常
排卵,精子生产或精子功能,以开发安全,有效,
为男性或女性提供负担得起的避孕药具。 生物试验机构(BTF)是
设计用于快速评估新的物质组合物、药物配方、递送
避孕和内分泌活动的系统和装置。 BTF提供整体项目
管理和能力,以支持临床前活动的所有阶段,
开发新的避孕方法:这些方法包括但不限于体外和体内
体内试验,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)
分析、动物活动和研究、活性药物成分(API)的生产,
工艺和产品开发、配方、临床批次生产、临床前启用
研究和相关任务导致提交研究性新药(IND)申请。
由BTF配制的化合物正在或将在非人灵长类动物中进行测试。 NICHD保持一个
非人灵长类动物群体,目的是在
人体试验 由BTF配制的化合物,
现行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的研究人员已经制定了评估这种药物的方案
该计划确定的高优先级候选人。BTF一直在与COR合作,
化学合成设施和CCTN以及CCTN的研究人员,
开发和测试候选化合物临床批次的适当配方。的
每种候选药物的下一次临床研究取决于临床批次的及时接收,
开始招募和登记过程。 目前正在进行临床试验的药物
的临床配方。 生物试验设施发挥着
在CDP的药物开发使命中发挥关键作用。
英文摘要
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.
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BIOLOGICAL TESTING FACILITY - "RESEARCH AND DEVELOPMENT OF PRECLINICAL CONTRACEPTIVES".
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资助金额:$16.06万
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负责人:TOUFAN PARMAN
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