BIOLOGICAL TESTING FACILITY (BTF) - DEVELOPMENT OF CONTRACEPTIVE PRODUCTS INTENDED FOR NON-SYSTEMIC DELIVERY

生物测试设施 (BTF) - 开发用于非系统分娩的避孕产品

• 批准号: 10936055
• 负责人: DEBORAH BUNIN
• 金额: $ 137.23万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2025-09-20
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10936055
• 关键词: Acute; Animals; Authorization documentation; Binding Proteins; Biological Assay; Biological Availability; Biological Products; Biological Testing; Canis familiaris; Cervical; 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; Evaluation; Excretory function; Female Contraceptive Agents; Fertility; Formulation; Generations; Genetic; Good Manufacturing Process; Implant; In Vitro; Injectable; Intramuscular; Intravenous; Investigational Drugs; Male Contraceptive Agents; Measures; Medical Device; Metabolism; Microsomes; Mission; Mus; National Institute of Child Health and Human Development; Oogenesis; Oral; Oryctolagus cuniculus; Ovary; Ovulation; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Placebos; Plasma; Plasma Proteins; Play; Preparation; Prevention; Process; Progress Reports; Property; Protocols documentation; Rattus; Regulation; Reporting; Research; Research Support; Role; Route; Safety; Services; Sheep; Sperm Maturation; Spermatogenesis; System; Teleconferences; Testing; Tissues; Toxic effect; Toxicokinetics; Toxicology; United States Food and Drug Administration; Uterus; Vagina; Woman; absorption; analytical method; authority; clinical lot; cytotoxicity; data sharing; design; drug testing; egg; good laboratory practice; in vivo; in vivo Model; lot production; manufacture; men; nonhuman primate; novel; novel therapeutics; penis; pharmacokinetics and pharmacodynamics; pre-clinical; product development; reproductive; reproductive organ; research clinical testing; sperm cell; sperm function; subcutaneous; timeline; vaginal microbiome

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, use cases for existing chemical matter, drug formulations, delivery systems, and devices for contraceptive and/or contraceptive-containing multipurpose prevention (cMPT) 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 capabilities include but are not limited to assays (in vitro, ex vivo and in vivo); 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 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 and conduct studies under current good laboratory practices (cGLP). The BTF 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）旨在快速评价新的物质组合物、现有化学物质的使用情况、药物制剂、给药系统和避孕和/或含避孕药的多用途预防（cMPT）活动装置。BTF提供全面的项目管理和能力，以支持根据新的避孕方法开发的非临床活动的所有阶段。这些功能包括但不限于分析（体外、离体和体内）;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）生产;工艺和产品开发;制剂;临床批量生产;临床前使能研究;以及导致提交试验用新药（IND）或试验用器械豁免（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，并根据现行药物非临床研究质量管理规范（cGLP）进行研究。BTF在CRB的产品开发使命中起着关键作用。