BIOLOGICAL TESTING FACILITY - STABILITY TESTING, CLINICAL FORMULATION DEVELOPMENT AND MANUFACTURING ACTIVITIES OF CONTRACEPTIVE AGENTS

在NICHD，校内人口健康研究司（DIPHR）的避孕发展方案（CDP）支持研究开发可破坏正常排卵、精子产生或精子功能的化合物，以开发安全、有效和负担得起的男女避孕药具。生物检测设备（BTF）是该过程中的关键组成部分，旨在允许快速评估新组合物-物质，药物制剂，输送系统以及避孕和内分泌活性装置。BTF提供全面的项目管理和能力，以支持根据开发新的避孕方法的临床前活动的所有阶段：这些包括但不限于体外和体内试验、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）的生产、工艺和产品开发、配方、临床批量生产、临床前使能研究和相关任务，导致提交研究新药（IND）申请。由BTF配制的化合物正在或将在非人类灵长类动物中进行测试。NICHD维持着一群非人类灵长类动物，目的是在人类受试者试验之前评估潜在的避孕药。BTF根据现行良好生产规范（cGMP）制备的化合物将允许在CDP避孕临床试验网络（CCTN，避孕临床试验）中进行临床评价。CCTN研究人员制定了方案来评估该计划确定为高优先级的候选药物。BTF一直在与化学合成设施和CCTN的CORs以及CCTN的研究人员合作，为候选化合物的临床批次开发和测试适当的配方。每个候选药物的下一个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配方进行稳定性测试。生物测试设施在CDP的药物开发任务中起着关键作用。

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-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 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, Contraceptive Clinical Trial). 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.