BIOLOGICAL TESTING FACILITY - RESEARCH, OPTIMIZATION, AND DEVELOPMENT OF CONTRACEPTIVE

生物测试设施 - 避孕药具的研究、优化和开发

• 批准号: 10576706
• 负责人: DEBORAH BUNIN
• 金额: $ 145.31万
• 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: 2021-11-17 至 2023-11-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10576706
• 关键词: Animals; Area; Biological Testing; Chemicals; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive Usage; Contraceptive methods; Contractor; Development; Documentation; Drug Formulations; Drug Kinetics; Endocrine; Enrollment; Evaluation; Excretory function; Formulation; Goals; Investigational New Drug Application; Metabolism; Methods; Mission; National Institute of Child Health and Human Development; Ovulation; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Phase; Plasma; Play; 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; in vitro Assay; in vivo; lot production; men; novel therapeutics; pharmacokinetics and pharmacodynamics; population health; pre-clinical; pre-clinical research; product development; programs; recruit; research and development; research clinical testing; research facility; sperm cell; sperm function; stability testing

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 chemical entities (NCE), 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 assays and in vivo studies, 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.

校内人口健康司的避孕开发计划 (CDP) NICHD 的研究支持开发可以扰乱正常排卵的化合物的研究， 以开发安全、有效和负担得起的精子生产或精子功能为目的 男性或女性的避孕药具。生物测试设施 (BTF) 旨在允许 快速评估新化学实体 (NCE)、药物配方、输送系统和设备 用于避孕和内分泌活性。 BTF 提供全面的项目管理和 根据新药物开发支持临床前活动所有阶段的能力 避孕方法：包括但不限于体外测定和体内研究， 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 活性药物成分 (API) 的研究、制造、工艺和产品 开发、配方、临床批量生产、临床前研究和相关任务 导致提交研究性新药 (IND) 申请。配制的化合物 BTF 是根据现行良好生产规范 (cGMP) 制备的，以允许临床 CDP 避孕临床试验网络 (CCTN) 中的评估。 CCTN调查员 制定方案来评估该计划确定为高度优先的候选药物。 BTF 一直与化学合成设施和 CCTN 的 COR 合作 与 CCTN 的研究人员一起开发和测试适合临床的制剂 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 及时收到临床批次即可开始招募和入组流程。药品 目前正在进行的临床试验需要对临床制剂进行稳定性测试。这 生物测试设施在 CDP 的药物开发任务中发挥着关键作用。