BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE RESEARCH AND DEVELOPMENT TASK ORDER

生物测试设施 - 避孕药研发任务单

• 批准号: 10263608
• 负责人: TOUFAN PARMAN
• 金额: $ 148.67万
• 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: 2020-09-04 至 2022-09-03
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10263608
• 关键词: Animal Husbandry; Animals; Area; 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 Drugs; Investigational New Drug Application; Metabolism; Methods; Mission; National Institute of Child Health and Human Development; Ovulation; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasma; Play; Preclinical Testing; 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; human subject; in vitro Assay; 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; safety study; sperm cell; sperm function; stability testing

Within the Division of Intramural Population Health Research (DIPHR), the Contraceptive Development Program (CDP) 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, or will be, tested in non-human 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 of the clinical formulations. The Biological Testing Facility plays a critical role in the drug development mission of the CDP.

在校内人口健康研究司内， NICHD的开发计划（CDP）支持研究开发可以破坏正常 排卵，精子生产或精子功能，以开发安全，有效， 为男性或女性提供负担得起的避孕药具。 生物试验机构（BTF）是 设计用于快速评估新的物质组合物、药物配方、递送 避孕和内分泌活动的系统和装置。 BTF提供整体项目 管理和能力，以支持临床前活动的所有阶段， 开发新的避孕方法：这些方法包括但不限于体外和体内 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、活性药物成分（API）的生产， 工艺和产品开发、配方、临床批次生产、临床前启用 研究和相关任务导致提交研究性新药（IND）申请。 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保持一个 非人灵长类动物群体，目的是在 人体试验 由BTF配制的化合物， 现行药品生产质量管理规范（cGMP）将允许在CDP避孕药中进行临床评价， 临床试验网络（CCTN）。CCTN的研究人员已经制定了评估这种药物的方案 该计划确定的高优先级候选人。BTF一直在与COR合作， 化学合成设施和CCTN以及CCTN的研究人员， 开发和测试候选化合物临床批次的适当配方。的 每种候选药物的下一次临床研究取决于临床批次的及时接收， 开始招募和登记过程。 目前正在进行临床试验的药物 的临床配方。 生物试验设施发挥着 在CDP的药物开发使命中发挥关键作用。