BIOLOGICAL TESTING FACILITY (BTF) - NONCLINICAL MALE CONTRACEPTIVE DEVELOPMENT SERVICES

生物测试设施 (BTF) - 非临床男性避孕开发服务

• 批准号: 10705348
• 负责人: DEBRA BURNIN
• 金额: $ 35.26万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-12 至 2024-09-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10705348
• 关键词: Acute; Animals; Binding Proteins; Biological Assay; Biological Availability; Biological Testing; Canis familiaris; Chemicals; Chronic; Clinical; Clinical Trials; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Contractor; Country; Data; Development; Devices; Documentation; Drug Exposure; Drug Formulations; Drug Kinetics; Drug Stability; Epididymis; Evaluation; Excretory function; Fertility; Formulation; Generations; Genetic; In Vitro; Intramuscular; Investigation; Investigational Drugs; Male Contraceptive Agents; Measures; Medical Device; Metabolic; Metabolism; Mission; Mus; National Institute of Child Health and Human Development; Oogenesis; Oral; Oryctolagus cuniculus; Ovulation; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Plasma; Plasma Proteins; Play; Preparation; Process; Progress Reports; Rattus; Regulation; Reporting; Research; Research Support; Role; Route; Safety; Services; Sheep; Sperm Maturation; Sperm Motility; Spermatogenesis; System; Teleconferences; Testis; TimeLine; Tissues; Toxic effect; Toxicokinetics; United States Food and Drug Administration; Vagina; Validation; Woman; absorption; analytical method; authority; clinical lot; cytotoxicity; design; egg; good laboratory practice; in vivo; in vivo Model; lot production; men; nonhuman primate; novel; novel therapeutics; pharmacokinetics and pharmacodynamics; pre-clinical; product development; reproductive organ; research clinical testing; sperm cell; subcutaneous

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 nonclinical 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 Biological Testing Facility plays a critical role in the product development mission of the CRB.

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 的避孕研究分部 (CRB) 支持研究开发能够破坏卵子发生、精子发生、正常排卵、精子成熟和/或功能的化合物，从而提供安全有效的避孕药具可以针对男性和/或女性实施。生物测试设施（BTF）旨在快速评估新的物质成分、药物配方、输送系统和避孕装置。 BTF 提供整体项目管理和支持新避孕方法开发的非临床活动所有阶段的能力：这些包括但不限于体外和体内测定、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 (PD) 分析、动物活动和研究、活性药物成分 (API) 的制造、工艺和产品开发、配方、临床批次生产、临床前支持研究以及导致提交研究性新药 (IND) 或研究性器械豁免 (IDE) 申请的相关任务。 BTF 有能力根据现行良好生产规范 (cGMP) 制备化合物以进行临床评估。生物测试设施在 CRB 的产品开发任务中发挥着关键作用。