BIOLOGICAL TESTING FACILITY, TASK ORDER 6: CONTRACEPTIVE FORMULATION DEVELOPMENT AND MANUFACTURING
BIOLOGICAL TESTING FACILITY, TASK ORDER 6: CONTRACEPTIVE FORMULATION DEVELOPMENT AND MANUFACTURING
批准号:
10369890
负责人:
Deborah Bunin
金额:
$97.1万
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
项目状态:
已结题
起止时间:
2021-03-05 至 2023-03-04
关键词:
AnimalsBiological AssayBiological TestingChemicalsClinicalClinical ResearchClinical TrialsClinical Trials NetworkContraceptive AgentsContraceptive DevicesContraceptive methodsContractorDevelopmentDocumentationDrug FormulationsEndocrineEnrollmentEvaluationExcretory functionFormulationIn VitroInvestigational New Drug ApplicationMetabolismMissionNational Institute of Child Health and Human DevelopmentOvulationPharmaceutical PreparationsPharmacologic SubstancePhasePlasmaPlayProcessProductionProgram DevelopmentProtocols documentationReportingResearch PersonnelResearch SupportRoleSystemTestingTimeToxic effectWomanabsorptionchemical synthesisclinical lotdesigndrug candidatedrug developmenthuman subjectin vivolot productionmennonhuman primatenovel therapeuticspharmacokinetics and pharmacodynamicspopulation healthpre-clinicalproduct developmentprogramsrecruitresearch and developmentresearch clinical testingsperm cellsperm functionstability testing
中文摘要
在NICHD,学院内的避孕发展方案(CDP)
人口健康研究(DIPHR)支持研究开发可以破坏
正常排卵、精子生成或精子功能发育为目的,安全、有效
以及为男性或女性提供的负担得起的避孕药具。生物试验机构(BTF)是一个
这一过程中的关键组成部分旨在快速评估新的物质组合物,
用于避孕和内分泌活动的药物制剂、递送系统和装置。
BTF提供全面的项目管理和支持所有阶段的能力,
根据新避孕方法的开发进行的临床前活动:这些活动包括,但
不限于体外和体内试验、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配制的化合物正在或将在非人类中进行测试
灵长类动物NICHD维持了一个非人灵长类动物群体,以评估
在人类受试者中进行试验之前,使用潜在的避孕药。由本发明人配制的化合物
根据现行药品生产质量管理规范(cGMP)制备的BTF将允许临床
CDP避孕临床试验网络(CCTN)。CCTN调查人员
已制定协议,以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。
英文摘要
At NICHD, the Contraceptive Development Program (CDP) within the Division of Intramural
Population Health Research (DIPHR) 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 a
critical component in this process designed to allow rapid evaluation of new compositions-ofmatter,
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 nonhuman
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 trials require stability testing 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, TASK ORDER 7: CONTRACEPTIVE PRECLINICAL RESEARCH AND DEVELOPMENT
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批准号:10369889
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项目类别:
-
资助金额:$108.78万
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财政年份:2021
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负责人:Deborah Bunin
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依托单位:
海外基金