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

NIH蓝图神经治疗网络（BPN）有一系列合作药物， 神经系统疾病的发现和开发项目，由Lead Development负责 团队（LDTs）。这些项目将通过迭代过程开发治疗线索， 药物化学优化以及体外和体内测试。这一进程的一个组成部分将是 进行化合物的体内药代动力学（PK）评估。承包商应进行 啮齿动物和非啮齿动物PK研究，以评估新的 BPN提供的化合物，以支持BPN下的药物化学优化工作。 本任务订单将涵盖啮齿动物的性能（例如，大鼠和小鼠）和非啮齿类动物（例如，犬、非人灵长类动物（NHP）、兔）的PK研究，由BPN计划生成，每年一次，持续5年。由于无法提前准确预测给定年份内需要进行的PK研究的实际数量，因此可以合理协商的最多是承包商在本任务订单的5年期间每年进行约6项啮齿类动物和2项非啮齿类动物药代动力学研究的相关人员和工作水平。应认识到，在给定年份，PK研究的实际数量和这些研究中的任务类型可能会因项目和待评估供试品的需求而异。 为编制提案，假设每年的研究数量和类型如下： · 6项大鼠药代动力学研究 · 1项犬单次给药药代动力学研究 · 1项单次给药NHP药代动力学研究

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