BIOLOGICAL TESTING FACILITY - CHARACTERIZATION OF POTENTIAL OVULATION INHIBITORS

生物测试设施 - 潜在排卵抑制剂的表征

• 批准号: 10021077
• 负责人: TOUFAN PARMAN
• 金额: $ 75万
• 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: 2019-09-27 至 2020-09-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10021077
• 关键词: Animals; Biological Assay; Biological Testing; Chemical Structure; Clinical; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Contracts; Development; Drug Formulations; Drug Kinetics; Endocrine; Evaluation; Excretory function; Formulation; In Vitro; Investigational New Drug Application; Measures; Metabolism; Methods; Microsomes; Mission; National Institute of Child Health and Human Development; Ovulation; Pharmacodynamics; Pharmacologic Substance; Phase; Plasma; Play; Process; Production; Research; Research Personnel; Research Support; Role; Safety; System; Testing; Toxic effect; Toxicology; Woman; absorption; chemical synthesis; clinical lot; design; drug development; in vitro Assay; in vivo; inhibitor/antagonist; lot production; men; novel therapeutics; pharmacokinetics and pharmacodynamics; pre-clinical; product development; research clinical testing; sperm cell; sperm function

Background: The Contraception Research Branch (CRB) within NICHD supports research to develop compounds that can disrupt normal ovulation, sperm production or sperm function so that safe and effective contraceptives can be developed for men or women. The Biological Testing Facility (BTF) is designed to permit 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 (ADME), toxicity, 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. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The BTF has been working with the Contracting Officer’s Representatives (CORs) for the Chemical Synthesis Facility and the Contraceptive Clinical Trials Network (CCTN) and with the investigators in the CCTN to develop and test the appropriate formulations for clinical batches of the candidate compounds. The BTF plays a critical role in the drug development mission of the CRB. Scope and Objectives: Preclinical activities of potential contraceptive products using either in-house or appropriate subcontract facilities as described in the Background including but not limited to the following: 1)Characterization of compounds including confirmation of chemical structure and development of appropriateformulations suitable for in vitro and in vivo studies. 2) Biologic testing of compounds and/or active pharmaceutical ingredients (API) by in vivo and in vitro assays to measure microsome stability, PK, PD, ADME, efficacy, safety and toxicology in appropriate vehicles and appropriate compound concentrations. These studies would support early characterization of compounds that would support eventual testing in clinical trials and ultimately toward filing a New Drug Application (NDA) for approval of a new method of achieving contraception.

背景： NICHD中的避孕研究部（CRB）支持研究，以开发可能破坏正常排卵，精子产生或精子功能的化合物，以便可以为男性或女性开发安全有效的避孕药。生物测试设施（BTF）旨在快速评估避孕药和内分泌活性的新物质，药物配方，输送系统和设备。 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, abstraction, distribution, metabolism, excretion (ADME), toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) profiling, animal activities and研究，生产活跃的药物用药（API），过程和产品开发，形成，临床批次生产，临床前启用研究以及相关任务，导致提出研究新药（IND）应用。 BTF具有在当前良好的制造实践（CGMP）下制备化合物的能力，以允许临床评估。 BTF一直与合同官员（CORS）合作，用于化学合成设施和避孕临床试验网络（CCTN），以及CCTN的研究人员开发和测试适当的候选化合物临床批次的配方。 BTF在CRB的药物开发任务中起着至关重要的作用。 范围和目标： 潜在避孕产品的临床前活动使用内部或适当的分包合同设施，如背景所述，包括但不限于以下内容： 1）化合物的表征，包括确认化学结构和适合体外和体内研究的适当形式的发展。 2）通过体内和体外测定的化合物和/或活性药物剂（API）的生物学测试，以测量适当车辆和适当的化合物浓度的微粒体稳定性，PK，PD，ADME，效率，安全性，安全性，安全性，安全性，安全性，安全性和毒理学。这些研究将支持对化合物的早期表征，这些化合物将支持临床试验中最终测试，并最终朝着提交新药物应用（NDA）以批准新的违约方法。