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：
DEBORAH BUNIN
金额：
$ 145.31万
依托单位：
SRI INTERNATIONAL
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：
https://reporter.nih.gov/project-details/10576706
关键词：
Animals Area Biological Testing Chemicals Clinical Clinical Research Clinical Trials Clinical Trials Network Contraceptive Agents Contraceptive Devices Contraceptive Usage Contraceptive methods Contractor Development Documentation Drug Formulations Drug Kinetics Endocrine Enrollment Evaluation Excretory function Formulation Goals Investigational New Drug Application Metabolism Methods Mission National Institute of Child Health and Human Development Ovulation Pharmaceutical Preparations Pharmacodynamics Pharmacologic Substance Phase Plasma Play Process Production Program Development Protocols documentation Reporting Research Research Personnel Research Support Role Route Safety System Testing Time Toxic effect Toxicology Woman absorption chemical synthesis clinical lot design drug candidate drug development in vitro Assay in vivo lot production men novel therapeutics pharmacokinetics and pharmacodynamics population health pre-clinical pre-clinical research product development programs recruit research and development research clinical testing research facility sperm cell sperm function stability 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.

室内人口健康部门内的避孕开发计划（CDP） NICHD的研究支持研究可以破坏正常排卵的化合物，精子生产或精子功能是为了开发安全，有效和负担得起的目的男性或女人的避孕药具。生物测试设施（BTF）旨在允许快速评估新化学实体（NCE），药物配方，输送系统和设备用于避孕和内分泌活动。 BTF提供了整体项目管理和根据新的发展，能够支持临床前活动的所有阶段避孕方法：其中包括但不限于体外测定和体内研究，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）分析，动物活动和研究，生产活性药物成分（API），过程和产品开发，配方，临床生产，临床前促进研究和相关任务导致提交研究新药（IND）应用。由 BTF是根据当前良好制造实践（CGMP）准备的，以允许临床 CDP避孕试验网络（CCTN）中的评估。 CCTN调查人员已经制定了协议，以评估该计划被确定为高优先级的毒品。 BTF一直在与CORS合作用于化学合成设施和CCTN和与CCTN中的研究人员一起开发和测试适当的临床配方候选化合物的批次。每种候选药物的下一项临床研究取决于及时收到临床批次以开始招募和入学过程。毒品目前正在进行的临床试验中需要对临床配方进行稳定测试。这生物测试设施在CDP的药物开发任务中起着至关重要的作用。