SRI TO 13 - CONTINUOUS RODENT AND NON-RODENT PHARMACOKINETIC ASSESSMENTS

SRI TO 13 - 连续啮齿动物和非啮齿动物药代动力学评估

• 批准号: 10719252
• 负责人: CAROL GREEN
• 金额: $ 38.02万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-17 至 2023-03-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10719252
• 关键词: Blood; Brain; Canis familiaris; Contractor; Development; Dose; Drug Kinetics; Human Resources; In Vitro; Lead; Mus; Oryctolagus cuniculus; Performance; Pharmaceutical Chemistry; Process; Rattus; Research Design; Rodent; Running; Series; Testing; Therapeutic; Tissues; United States National Institutes of Health; base; drug development; drug discovery; in vivo; in vivo evaluation; nervous system disorder; nonhuman primate; novel; programs

The NIH Blueprint Neurotherapeutics Network (BPN) has a series of collaborative drug discovery and development projects focused on nervous system disorders, run by Lead Development Teams (LDTs). These projects will be developing therapeutic leads through an iterative process of medicinal chemistry optimization and in vitro and in vivo testing. A component of this process will be the conduct of in vivo pharmacokinetic (PK) assessment of compounds. The contractor shall conduct rodent and non-rodent PK studies to assess blood and tissue (primarily brain) levels of a novel compound supplied by the BPN to support medicinal chemistry optimization efforts under the BPN. This task order will cover the performance of rodent (e.g., rat and mouse) and non-rodent (e.g., dog, non-human primate (NHP), rabbit) PK studies of test articles generated by the BPN Initiative, on a yearly basis, for the next five (5) years. Since the actual number of PK studies that will be needed within a given year cannot be accurately predicted in advance, the most that can be fairly bargained for is for the Contractor to have available the personnel and level of effort associated with performing approximately 6 rodent and 2 non-rodent pharmacokinetic studies per year during the five-year period of this task order. It is recognized that the actual number of PK studies and types of tasks within these studies, in a given year, may vary based on the needs of the program and test article being assessed. For the purposes of proposal development, assume the following number and types of studies for each year: • Six (6) rat pharmacokinetic studies • One (1) single dose dog pharmacokinetic study • One (1) single dose NHP pharmacokinetic study

NIH蓝图神经疗法网络（BPN）有一系列协作药物 由铅开发运行的针对神经系统障碍的发现和开发项目 团队（LDT）将开发出治疗性的潜在客户 药物化学优化和体外测试。 承包商的体内药代动力学（PK）评估应进行。 啮齿动物和非刺激PK研究，以评估新型血液和组织（主要是大脑）水平 BPN提供的化合物以支持BPN下的药物化学优化源具。 这家ORL涵盖了啮齿动物（例如，老鼠和小鼠）和非岩体（例如，狗，非人类灵长类动物（NHP），兔子）ICLE的表现，由BPN倡议产生，在接下来的五个基础上，在接下来的五个基础上（5） ）由于无法准确预测给定AEAR内部所需的行为，因此可以对承包商进行相当讨价还价的OST。订单。在给定的一年中，可以根据程序和测试文章的评估来确认螺纹中的实际数量和线程中的任务类型。 出于提案开发的目的，假设每年的研究数量和类型： •六（6）大鼠药代动力学研究 •一（1）个单剂量狗药代动力学研究 •一（1）个单剂量NHP药代动力学研究