BIOLOGICAL TESTING FACILITY – "QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP"

在内部人口健康研究司(DIPHR)内，避孕药具 NICHD的开发计划(CDP)支持化合物的研究和开发 会为了发育而扰乱正常的排卵、精子产生或精子功能 安全、有效和负担得起的男性或女性避孕药具。生物检测设施 (BTF)旨在允许发现和快速评估新的物质成分、药物 用于避孕和内分泌活动的制剂、给药系统和装置。北京交响乐团 提供全面的项目管理和支持临床前所有阶段的能力 根据开发新的避孕方法开展的活动：这些方法包括但不限于 在计算机模拟、体外和体内分析中，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，活性物质的制造 药物成分(原料药)、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报告 新药(IND)申请。由BTF配制的在电流作用下制备的化合物 良好生产规范(CGMP)将允许对CDP避孕药进行临床评估 临床试验网络(CCTN)。CCTN调查人员已经制定了评估方案 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CORS以及 CCTN为候选人的临床批次开发和测试适当的配方 化合物。生物测试设施在药物开发任务中发挥着关键作用 CDP的。

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.