BIOLOGICAL TESTING FACILITY (BTF) - FORMULATION AND PHARMACEUTICAL CHARACTERIZATION OF MULTIPURPOSE PREVENTION CONTRACEPTION PREVENTION

生物测试设施 (BTF) - 多用途预防避孕药的配方和药物特性

• 批准号: 10932080
• 负责人: DEBRA BURNIN
• 金额: $ 5万
• 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 2024-06-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10932080
• 关键词: ADME Study; Adhesions; Animals; Biological Assay; Biological Testing; Buffers; Clinical; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Crystal Formation; Development; Devices; Drug Formulations; Evaluation; Formulation; Gel; Good Manufacturing Process; High Pressure Liquid Chromatography; In Vitro; Investigational Drugs; Microsomes; Mission; National Institute of Child Health and Human Development; Oogenesis; Ovulation; Particle Size; Pharmacologic Substance; Phase; Plasma; Play; Prevention; Process; Research; Research Personnel; Research Support; Rheology; Role; Sperm Maturation; Spermatogenesis; System; Testing; Toxic effect; Viscosity; Woman; chemical synthesis; clinical lot; design; evaluation/testing; in vivo; lot production; manufacture; men; pharmacokinetics and pharmacodynamics; pre-clinical; product development; research clinical testing; sperm function

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-ofmatter, 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 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.

尤妮斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所的避孕研究分支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，从而为男性和/或女性提供安全有效的避孕药具。生物试验设施（BTF）的目的是允许快速评价新的物质组合物，药物配方，输送系统和避孕活性装置。BTF提供全面的项目管理和能力，以支持根据新避孕方法开发的所有阶段的非临床活动：这些包括但不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、临床前使能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有能力根据现行药品生产质量管理规范（cGMP）制备化合物，以进行临床评价。BTF一直与化学合成机构和CCTN的COR以及CCTN的研究人员合作，开发和测试候选化合物临床批次的适当形成。生物试验机构在CRB的产品开发使命中发挥着关键作用。