BIOLOGICAL TESTING FACILITY – IN VITRO METABOLIC AND IN VIVO PRECLINICAL STUDIES

生物测试设施 – 体外代谢和体内临床前研究

• 批准号: 10705350
• 负责人: DEBRA BURNIN
• 金额: $ 60.49万
• 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/10705350
• 关键词: Androgens; Animal Model; Animals; Area; Biological Testing; Blood; Chemicals; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive Usage; Contraceptive methods; Contractor; Development; Documentation; Drug Evaluation; Drug Formulations; Drug Kinetics; Endocrine; Enrollment; Evaluation; Excretory function; Formulation; Goals; Hormones; In Vitro; Injectable; Investigational New Drug Application; Metabolic; Metabolism; Methods; Mission; National Institute of Child Health and Human Development; Oral; Ovulation; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Phase; Plasma; Play; Process; Prodrugs; Production; Progestins; Program Development; Proteins; Protocols documentation; Reporting; Research; Research Personnel; Research Support; Role; Route; Safety; System; Testing; Time; Tissues; Toxic effect; Toxicology; Woman; absorption; androgenic; chemical synthesis; clinical lot; design; drug candidate; drug development; efficacy evaluation; estrogenic; in vitro Assay; in vivo; lot production; men; novel therapeutics; pharmacokinetics and pharmacodynamics; population health; pre-clinical; pre-clinical research; preclinical study; product development; programs; recruit; research and development; research clinical testing; sperm cell; sperm function; stability testing

Within Division of Intramural Population Health Research at NICHD, the Contraceptive Development Program (CDP) supports research to develop potential contraceptive compounds that can disrupt normal ovulation, sperm production or sperm function for the purpose of developing safe, effective, and affordable contraceptives for women or men. 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.

在 NICHD 校内人口健康研究部门内，避孕开发计划 (CDP) 支持研究开发潜在的避孕化合物，这些化合物可以扰乱正常排卵、精子生成或精子功能，以便为女性或女性开发安全、有效且负担得起的避孕药具。男人。生物测试设施 (BTF) 旨在快速评估新化学实体 (NCE)、药物配方、输送系统以及避孕和内分泌活性装置。 BTF 提供整体项目管理和支持新避孕方法开发的临床前活动所有阶段的能力：这些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、导致提交研究性新药 (IND) 申请的临床前支持研究和相关任务。 BTF 配制的化合物是根据现行良好生产规范 (cGMP) 制备的，以便在 CDP 避孕临床试验网络 (CCTN) 中进行临床评估。 CCTN 调查人员已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 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配方。每种候选药物的下一次临床研究取决于及时收到临床批次以开始招募和登记过程。目前正在进行临床试验的药物需要对临床制剂进行稳定性测试。生物测试设施在 CDP 的药物开发任务中发挥着关键作用。