BIOLOGICAL TESTING FACILITY – "QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP"

生物测试设施 — “定量结构活性关系”

• 批准号: 10361636
• 负责人: DEBORAH BUNIN
• 金额: $ 12.57万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-07 至 2022-01-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10361636
• 关键词: Affinity; Androgens; Animals; Binding; Biological Assay; Biological Testing; Clinical; Clinical Trials Network; Computer Models; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Data; Development; Drug Formulations; Endocrine; Estrogens; Evaluation; Excretory function; Formulation; In Vitro; Investigational New Drug Application; Ligands; Measures; Metabolism; Mission; Modeling; National Institute of Child Health and Human Development; Ovulation; Pharmacologic Substance; Phase; Plasma; Play; Process; Production; Progesterone; Program Development; Protocols documentation; Quantitative Structure-Activity Relationship; Research; Research Personnel; Research Support; Role; Steroid Receptors; Structure; Structure-Activity Relationship; System; Techniques; Testing; Toxic effect; Woman; absorption; base; chemical synthesis; cheminformatics; clinical lot; design; drug candidate; drug development; in silico; in vivo; lot production; men; pharmacokinetics and pharmacodynamics; population health; pre-clinical; predictive modeling; product development; programs; research and development; research clinical testing; sperm cell; sperm function; steroid analog

Within the Division of Intramural Population Health Research (DIPHR), the Contraceptive Development Program (CDP) at NICHD supports research and development of compounds that can disrupt normal ovulation, sperm production or sperm function for the purpose of developing safe, effective and affordable contraceptives for men or women. The Biological Testing Facility (BTF) is designed to allow discovery and rapid evaluation of new compositions-of-matter, 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 in silico/computational modeling, to in vitro and in vivo assays, 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 that are prepared under current Good Manufacturing Practices (cGMP) will 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 (CSF) 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 Biological Testing Facility plays a critical role in the drug development mission of the CDP.

在校内人口健康研究司内， NICHD的开发计划（CDP）支持化合物的研究和开发， 可以破坏正常排卵，精子生产或精子功能，以促进发育 安全、有效和负担得起的男女避孕药具。生物试验机构 (BTF)旨在发现和快速评估新的物质组合物，药物 用于避孕和内分泌活性的制剂、递送系统和装置。BTF 提供全面的项目管理和支持临床前所有阶段的能力 为开发新的避孕方法而开展的活动：包括但不限于 体外和体内试验、血浆和微粒体稳定性的计算机模拟/计算建模 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，活性药物的生产 药物成分（API）、工艺和产品开发、配方、临床批次 生产、临床前使能研究和相关任务，导致提交研究性 新药申请（IND）由BTF配制的化合物在当前条件下制备， 药品生产质量管理规范（cGMP）将允许在CDP避孕药中进行临床评价。 临床试验网络（CCTN）。CCTN研究人员已经制定了方案来评估 被该计划确定为高度优先的候选药物。BTF一直在与 化学合成设施（CSF）和CCTN的COR以及研究人员在 CCTN开发和检测候选药物临床批次的适当制剂 化合物.生物试验机构在药物开发使命中发挥着关键作用 的CDP。