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”。

基本信息

批准号：
10183638
负责人：
TOUFAN PARMAN
金额：
$ 76.68万
依托单位：
SRI INTERNATIONAL
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：
2020-04-29 至 2022-04-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10183638
关键词：
Animals Biological Assay Biological Testing Clinical Clinical Research Clinical Trials Clinical Trials Network Consultations Contraceptive Agents Contraceptive Devices Contraceptive Usage Contraceptive methods Contractor Development Documentation Drug Formulations Endocrine Enrollment Evaluation Excretory function Formulation Gel Implant In Vitro Injectable Investigational New Drug Application Levonorgestrel Metabolism Methods Mission National Institute of Child Health and Human Development Nestorone Ovulation Pharmaceutical Preparations Pharmacologic Substance Phase Plasma Play Process Production Program Development Protocols documentation Reporting Research Research Personnel Research Support Role Safety System Tablets Testing Testosterone Time Toxic effect Woman absorption capsule chemical synthesis clinical lot design drug candidate drug development in vivo lot production men pharmacokinetics and pharmacodynamics population health pre-clinical preclinical development product development programs recruit 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 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 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.

NICHD壁内人群健康研究部门内的避孕开发计划（CDP）支持开发可能破坏正常排卵，精子产生或精子的化合物目的是为男女开发安全，有效和负担得起的避孕药具。生物测试设施（BTF）旨在快速评估新的物质，药物用于避孕和内分泌活动的配方，输送系统和设备。 BTF提供了整体项目管理和支持根据开发的临床前活动的所有阶段的能力 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生产，临床前研究和相关任务，导致提出研究新药（IND）应用。由BTF制定的化合物是根据当前良好的制造实践（CGMP）制备的，以允许在CDP避孕临床试验网络（CCTN）中进行临床评估。 CCTN研究人员已经制定了协议，以评估该计划被确定为高优先级的候选药物。 BTF一直与CORS合成化学合成设施和CCTN以及CCTN中的研究人员开发和测试适当的候选化合物临床批次配方。每种候选药物的下一项临床研究取决于及时接收临床批次，以开始招募和入学过程。目前正在进行的临床试验的药物需要稳定测试临床配方。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。