BIOLOGICAL TESTING FACILITY, TASK ORDER 6: CONTRACEPTIVE FORMULATION DEVELOPMENT AND MANUFACTURING

在NICHD，校内部门内的避孕发展计划(CDP) 人口健康研究(DIPHR)支持研究开发能够破坏 以正常排卵、精子产生或精子功能发育为目的的安全、有效 为男性或女性提供负担得起的避孕药具。生物检测机构(BTF)是一家 这一过程中的关键组件，旨在允许快速评估新的成分-物质， 用于避孕和内分泌活动的药物配方、给药系统和装置。 BTF提供全面的项目管理和支持所有阶段的能力 根据开发新的避孕方法开展的临床前活动：这些方法包括，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。BTF配制的化合物正在或将在非人类身上进行测试 灵长类动物。NICHD维持着一群非人类灵长类动物，目的是评估 潜在的避孕药在人类受试者试验前。由该公司配制的化合物 根据当前良好制造规范(CGMP)准备的BTF将允许临床 在CDP避孕临床试验网络(CCTN)中的评估。CCTN调查人员 制定方案以评估被该计划确定为高优先级的候选药物。 BTF一直与化学合成设施和CCTN的CORS合作，并 与CCTN的研究人员一起开发和测试适用于临床的配方 候选化合物的批次。每种候选药物的下一项临床研究都是依赖于 在及时收到临床批次后，开始招生录取工作。毒品 目前正在进行的临床试验需要对临床制剂进行稳定性测试。这个 生物测试设施在CDP的药物开发任务中发挥着关键作用。

At NICHD, the Contraceptive Development Program (CDP) within the Division of Intramural Population Health Research (DIPHR) supports research to develop 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 a critical component in this process designed to allow rapid evaluation of new compositions-ofmatter, 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 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 are, or will be, tested in nonhuman primates. NICHD maintains a colony of non-human primates for the purpose of evaluating potential contraceptive agents prior to trials in human subjects. 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 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.