BIOLOGICAL TESTING FACILITY - DISCOVERY, CLINICAL FORMULATION, AND MANUFACTURE OF CONTRACEPTIVES

NICHD人口健康研究部(DiPHR)内的避孕开发计划(CDP)支持研究开发可能扰乱正常排卵、精子产生或精子功能的化合物，目的是为女性或男性开发安全、有效和负担得起的避孕药。生物检测设施(BTF)是这一过程中的关键组成部分，旨在快速评估新的物质成分、药物配方、给药系统和避孕和内分泌活动装置。BTF根据新避孕方法的开发提供全面的项目管理和能力，以支持临床前活动的所有阶段，这些方法包括但不限于行政支持、避孕靶标发现数据库、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)概况、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、临床批量生产、临床前使能研究和导致提交研究性新药(IND)申请的相关任务。BTF配制的化合物正在或将进行测试，包括但不限于非人类灵长类动物。由BTF根据当前良好制造规范(CGMP)配制的化合物将允许在CDP避孕临床试验网络(CCTN)中进行临床评估。CCTN调查人员已经制定了方案，以评估被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的调查人员合作，为候选化合物的临床批次开发和测试适当的配方。每种候选药物的下一步临床研究取决于是否及时收到临床批次，以开始招募和招募过程。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的药物开发任务中发挥着关键作用。

The Contraceptive Development Program (CDP)) within the Division of Population Health Research (DiPHR) at NICHD 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 women or men. 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 administrative support, contraceptive target discovery database, 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 including but not limited to non-human primates. 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.