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
• 负责人: DEBORAH BUNIN
• 金额: $ 109.81万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-18 至 2025-08-17
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10923031
• 关键词: ADME Study; Animals; Biological Assay; Biological Testing; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Contractor; Databases; Development; Drug Formulations; Endocrine; Enrollment; Evaluation; Formulation; Gel; Good Manufacturing Process; Implant; In Vitro; Injectable; Investigational New Drug Application; Methods; Microsomes; Mission; National Institute of Child Health and Human Development; Nestorone; Oral; Ovulation; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasma; Play; Process; Production; Program Development; Protocols documentation; Report (document); Research; Research Personnel; Research Support; Role; System; Testing; Testosterone; Time; Toxic effect; Woman; candidate identification; chemical synthesis; clinical lot; contraceptive target; design; drug candidate; drug development; in vivo; lot production; manufacture; manufacturing test; men; new chemical entity; nonhuman primate; novel therapeutics; pharmacokinetics and pharmacodynamics; population health; pre-clinical; preclinical study; product development; programs; recruit; research and development; research clinical testing; sperm cell; sperm function; stability testing

The Contraceptive Development Program (CDP)) within the Division of Population Health Research (DiPHR) 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 women or men. The Biological Testing Facility (BTF) is a critical component in this process 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 administrative support, contraceptive target discovery database, 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 including but not limited to non-human primates. 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.

NICHD的人口健康研究（DIPHR）内的避孕开发计划（CDP）支持开发可破坏正常排卵，精子产生或精子功能的化合物，以开发女性或男性的安全，有效且负担得起的避孕药。生物测试设施（BTF）是此过程中的关键组成部分，旨在快速评估避孕和内分泌活性的新物质，药物配方，输送系统和设备。 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 administrative support, contraceptive target discovery database, in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion and toxicity (ADMET), pharmacokinetic (PK) and药效（PD）分析，动物活动和研究，活性药物成分（API）的生产，过程和产品开发，配方，临床批次生产，临床前促进研究以及相关任务，导致提出研究新药（IND）应用。由BTF制定的化合物是或将被测试，包括但不限于非人类灵长类动物。由BTF制定的化合物是根据当前良好的制造实践（CGMP）制备的，将允许在CDP避孕试验网络（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对临床配方进行稳定性测试。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。