"ANALYTICAL SUPPORT AND PK SAMPLE ANALYSIS FOR PRECLINICAL PHARMACOLOGY STUDIES"

“临床前药理学研究的分析支持和 PK 样品分析”

• 批准号: 10037669
• 负责人: JAN BEUMER
• 金额: $ 2.59万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2024-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10037669
• 关键词: Antineoplastic Agents; Contractor; Data; Drug Kinetics; Life; Methodology; Mus; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology Study; Pharmacology and Toxicology; Plasma; Running; Sampling; Specific qualifier value; Therapeutic Agents; Validation; base; cost; pre-clinical; small molecule; tumor

The purpose of this Task Order is to provide analytical support for the quantification of putative therapeutic agents in plasma and/or tumor samples to be provided by NCI. Pharmacokinetic analysis to the extent allowed by the data shall also be performed. Rapid turn-around is required. There is a base effort and nine options under this task order. The contractor shall provide analytical support for the quantification of small-molecule anticancer agents in plasma and/or tumor samples to be provided by NCI. These samples may be derived from efficacy or pharmacodynamic studies in mice or other pharmacology/toxicology studies to be specified. The in-life portion of all studies will be conducted at other NCI-designated facilities. Assume for costing purposes that a total 400 samples will be provided for quantification of one compound and that there will be no more than two matrices (e.g., plasma, tumor fragments). The following specific activities shall be carried out for the Base Task: 1. Implement LC-MS/MS methodology for the quantification of the compounds in plasma and tumor samples and perform limited validation as required. Standard approaches suitable for discovery studies shall be used. Assume a drug-like small molecule of ~300-900 MW. 2. Determine levels of the compound in a total of 400 unknown samples to be provided to you by NCI. Run appropriate blanks, standards, and QC samples. Control matrix will be provided to the extent available. 3. Non-compartmental PK parameters (Cmax, Tmax, AUC, t1/2,], etc.) should be calculated (as permitted by the data obtained).

该任务顺序的目的是为NCI提供的等离子体和/或肿瘤样本中假定的治疗剂的定量提供分析支持。还应在数据允许的范围内进行药代动力学分析。需要快速转弯。在此任务订单下有基本的努力和九个选项。 承包商应为NCI提供的血浆和/或肿瘤样品中的小分子抗癌剂定量提供分析支持。这些样品可以来自小鼠或其他药理学/毒理学研究的功效或药效研究。 所有研究的生活部分将在其他NCI指定的设施进行。假设出于成本核算的目的，将提供400个样品来定量一种化合物，并且将不超过两个矩阵（例如，血浆，肿瘤片段）。 应为基本任务进行以下特定活动： 1。实施LC-MS/MS方法，以定量血浆和肿瘤样品中的化合物，并根据需要执行有限的验证。应使用适合发现研究的标准方法。假设一个〜300-900兆瓦的药物样小分子。 2。确定NCI总共提供400个未知样品的化合物水平。 运行适当的空白，标准和QC样本。 将在可用范围内提供控制矩阵。 3。应计算非室内PK参数（CMAX，TMAX，AUC，T1/2]等）（根据获得的数据允许）。