BIOLOGICAL TESTING FACILITY - "RESEARCH AND DEVELOPMENT OF PRECLINICAL CONTRACEPTIVES".

NICHD 校内人口健康研究部的避孕开发计划 (CDP) 支持开发可扰乱正常排卵、精子生成或精子的化合物的研究 旨在为男性或女性开发安全、有效和负担得起的避孕药具。生物测试设施 (BTF) 旨在快速评估新的物质成分、药物 用于避孕和内分泌活性的制剂、输送系统和装置。 BTF 提供整体项目管理和根据开发支持临床前活动所有阶段的能力 新的避孕方法：包括但不限于体外和体内测定、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）的制造、工艺和产品开发、配方、临床批量生产、临床前支持研究以及导致提交研究性新药（IND）申请的相关任务。 BTF 配制的化合物是根据现行良好生产规范 (cGMP) 制备的，以便在 CDP 避孕临床试验网络 (CCTN) 中进行临床评估。 CCTN 调查人员已制定方案来评估该计划确定为高度优先的候选药物。 BTF 一直与化学合成设施和 CCTN 的 COR 以及 CCTN 的研究人员合作，开发和测试候选化合物临床批次的适当配方。每种候选药物的下一次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稳定性 临床制剂的测试。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 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 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 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.