BIOLOGICAL TESTING FACILITY - FORMULATION DEVELOPMENT CLINICAL MANUFACTURING AND STABILITY TESTING

背景： NICHD内部人群健康研究部内的避孕开发计划(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，目的是为男性或女性开发安全、有效和负担得起的避孕药。生物测试设施(BTF)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。由BTF配制的化合物是根据当前的良好制造规范(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。 范围和目标： 使用内部或适当的分包设施的避孕药具的配方开发、临床制造和稳定性测试，如背景所述，将适合用于临床试验 潜在的避孕产品将得到这项任务的支持。这项任务要求承包商提供文件和研究报告，以支持严格的监管机构可以接受的监管备案。

Background: 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. Scope and Objectives: Formulation development, clinical manufacturing and stability testing of contraceptives using in house or appropriate subcontract facilities as described in the Background that will be suitable for use in clinical trials of a potential contraceptive products will be supported by this task. The task requires that the contractor provide documentation and reports of studies to support regulatory filings acceptable to stringent regulatory agencies.