BIOLOGICAL TESTING FACILITY - "CONTRACEPTIVE DRUG AND INTRAVAGINAL CONTRACEPTIVE DEVICE EVALUATION"

生物测试设施 - “避孕药物和阴道内避孕器具评估”

• 批准号: 10271538
• 负责人: TOUFAN PARMAN
• 金额: $ 70万
• 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: 2020-09-22 至 2021-09-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10271538
• 关键词: Animals; Biological Assay; Biological Testing; Chemicals; Clinical; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Data; Development; Device or Instrument Development; Devices; Drug Formulations; Drug Kinetics; Evaluation; Excretory function; Female Contraceptive Agents; Formulation; In Vitro; Investigation; Investigational Drugs; Male Contraceptive Agents; Metabolism; Mission; National Institute of Child Health and Human Development; Oogenesis; Ovulation; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Plasma; Play; Process; Research; Research Personnel; Research Support; Role; Safety; Services; Sperm Maturation; Spermatogenesis; System; Testing; Toxic effect; United States Food and Drug Administration; Woman; absorption; chemical synthesis; clinical lot; design; in vivo; lot production; men; novel; novel therapeutics; pharmacokinetics and pharmacodynamics; pre-clinical; product development; research clinical testing

The Contraception Research Branch (CRB) within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports research to develop compounds that can disrupt oogenesis, spermatogenesis, normal ovulation, sperm maturation and/or function affording safe and effective contraceptives that can be implemented for men and/or women. The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions-of- matter, drug formulations, delivery systems, and devices for contraceptive activity. The BTF provides overall project management and the capabilities to support all phases of preclinical activities pursuant to development of new contraceptives methods: these include, but are not limited to in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion (ADME), toxicity, 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) or Investigational Device Exemption (IDE) applications. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The BTF has been working with the CORs for the Chemical Synthesis Facility and the CCTN and with investigators in the CCTN to develop and test the appropriate formation for clinical batches of the candidate compounds. The Biological Testing Facility plays a critical role in the product development mission of the CRB.

尤尼斯·肯尼迪·施莱弗国家研究院内的避孕研究分会 儿童健康和人类发展(NICHD)支持研究开发能够破坏人类健康的化合物 卵子发生、精子发生、正常排卵、精子成熟和/或提供 可为男性和/或女性实施的安全有效的避孕措施。《生物》 测试设施(BTF)旨在允许快速评估新的物质成分、药物 用于避孕活动的制剂、给药系统和装置。BTF提供了 全面的项目管理和支持临床前所有阶段的能力 根据开发新的避孕方法开展的活动：这些方法包括，但 不仅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(ADME)、毒性、 药代动力学(PK)和药效学(PD)分析、动物活动和 活性药物成分(原料药)、工艺和产品的研究、制造 开发、配方、临床批量生产、临床前使能研究和相关 导致研究新药(IND)或研究设备备案的任务 豁免(IDE)应用程序。BTF具有在电流作用下制备化合物的能力 良好的制造规范(CGMP)，以进行临床评估。BTF一直在与 化学合成设施和CCTN的CORS以及CCTN的调查人员 为候选化合物的临床批次开发和测试合适的构型。这个 生物测试设施在CRB的产品开发任务中发挥着关键作用。