BIOLOGICAL TESTING FACILITY - RESEARCH, OPTIMIZATION, AND DEVELOPMENT OF CONTRACEPTIVE

校内人口健康处的避孕发展计划(CDP) NICHD的研究支持开发能够扰乱正常排卵的化合物的研究， 为了开发安全、有效和负担得起的精子而产生精子或精子功能 男性或女性的避孕药。生物检测设施(BTF)旨在允许 快速评估新的化学实体(NCE)、药物配方、给药系统和设备 用于避孕和内分泌活动。BTF提供全面的项目管理和 能够根据新的开发支持临床前活动的所有阶段 避孕方法：包括但不限于体外试验和体内研究， 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)图谱、动物活动 以及研究、生产活性药物成分(原料药)、工艺和产品 开发、配方、临床批量生产、临床前支持研究和相关任务 导致研究新药(IND)申请的提交。化合物配方如下： BTF是根据当前的良好制造规范(CGMP)准备的，以允许临床 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。

The Contraceptive Development Program (CDP) within Division of Intramural Population Health Research 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 men or women. The Biological Testing Facility (BTF) is designed to allow rapid evaluation of new chemical entities (NCE), 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 assays and in vivo studies, 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 prepared under current Good Manufacturing Practices (cGMP) to 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.