BIOLOGICAL TESTING FACILITY - FORMULATION DEVELOPMENT CLINICAL MANUFACTURING AND STABILITY TESTING

生物测试设施 - 制剂开发、临床制造和稳定性测试

• 批准号: 10266724
• 负责人: TOUFAN PARMAN
• 金额: $ 35万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-05 至 2020-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266724
• 关键词: Animals; Biological Assay; Biological Testing; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive Usage; Contraceptive methods; Contractor; Development; Documentation; Drug Formulations; Endocrine; Enrollment; Evaluation; Excretory function; Formulation; In Vitro; Investigational New Drug Application; Metabolism; Mission; National Institute of Child Health and Human Development; Ovulation; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasma; Play; Process; Production; Program Development; Protocols documentation; Reporting; Research; Research Personnel; Research Support; Role; System; Testing; Time; Toxic effect; Woman; absorption; chemical synthesis; clinical development; clinical lot; design; drug candidate; drug development; in vivo; lot production; men; pharmacokinetics and pharmacodynamics; population health; pre-clinical; product development; programs; recruit; research clinical testing; sperm cell; sperm function; stability testing

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.

背景： NICHD 校内人口健康研究部的避孕开发计划 (CDP) 支持研究开发可扰乱正常排卵、精子生成或精子功能的化合物，以便为男性或女性开发安全、有效且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、药物配方、输送系统以及避孕和内分泌活性装置。 BTF 提供整体项目管理和支持新避孕方法开发的临床前活动所有阶段的能力：这些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 (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对临床制剂进行稳定性测试。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： 使用背景中描述的内部或适当的分包设施进行避孕药具的配方开发、临床制造和稳定性测试，这些设施将适用于临床试验 这项任务将支持潜在的避孕产品。该任务要求承包商提供文件和研究报告，以支持严格监管机构可接受的监管备案。