BIOLOGICAL TESTING FACILITY, TASK ORDER 6: CONTRACEPTIVE FORMULATION DEVELOPMENT AND MANUFACTURING

生物测试设施，任务令 6：避孕制剂的开发和制造

• 批准号: 10369890
• 负责人: Deborah Bunin
• 金额: $ 97.1万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-05 至 2023-03-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10369890
• 关键词: Animals; Biological Assay; Biological Testing; Chemicals; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Contractor; Development; Documentation; 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; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasma; Play; Process; Production; Program Development; Protocols documentation; Reporting; Research Personnel; Research Support; Role; 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; novel therapeutics; 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-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.

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 已制定方案来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。