BIOLOGICAL TESTING FACILITY - STABILITY TESTING, CLINICAL FORMULATION DEVELOPMENT AND MANUFACTURING ACTIVITIES OF CONTRACEPTIVE AGENTS

生物测试设施 - 避孕药的稳定性测试、临床制剂开发和生产活动

• 批准号: 10618518
• 负责人: DEBRA BURNIN
• 金额: $ 119.95万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-30 至 2025-08-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618518
• 关键词: Animals; Biological Assay; Biological Testing; Chemicals; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Contracts; Development; Drug Formulations; Endocrine; Enrollment; Evaluation; Excretory function; Formulation; In Vitro; Investigational New Drug Application; Metabolism; Mission; National Institute of Child Health and Human Development; Ovulation; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasma; Play; Process; Production; Program Development; Protocols documentation; Research Personnel; Research Support; Role; Services; System; Testing; Time; Toxic effect; Woman; absorption; chemical synthesis; clinical lot; design; drug candidate; drug development; human subject; in vivo; lot production; men; nonhuman primate; pharmacokinetics and pharmacodynamics; population health; pre-clinical; product development; programs; recruit; research and development; research clinical testing; sperm cell; sperm function; stability testing

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-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 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, Contraceptive Clinical Trial). 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.

在NICHD，校内人口健康研究司（DIPHR）内的避孕开发方案（CDP）支持研究开发能够破坏正常排卵、精子产生或精子功能的化合物，目的是为男性或女性开发安全、有效和负担得起的避孕药具。生物试验设施（BTF）是这一过程中的一个关键组成部分，旨在快速评价新的物质组合物、药物配方、给药系统和避孕及内分泌活性装置。BTF提供全面的项目管理和能力，以支持根据新避孕方法开发的临床前活动的所有阶段：这些包括但不限于体外和体内分析，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、临床批量生产、临床前使能研究以及导致提交研究性新药（IND）申请的相关任务。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维持了一个非人灵长类动物群体，目的是在人类受试者试验之前评估潜在的避孕药。由BTF根据现行药品生产质量管理规范（cGMP）配制的化合物将允许在CDP避孕临床试验网络（CCTN，避孕临床试验）中进行临床评价。CCTN研究人员已经制定了方案，以评估该计划确定为高优先级的候选药物。BTF一直在与化学合成机构和CCTN的COR以及CCTN的研究人员合作，开发和测试候选化合物临床批次的适当配方。每种候选药物的下一项临床研究取决于是否及时收到临床批次，以开始招募和入组过程。目前正在进行临床试验的药物需要进行临床制剂的稳定性试验。生物试验机构在CDP的药物开发使命中发挥着关键作用。