"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: 10449188
• 负责人: JAN BEUMER
• 金额: $ 4.17万
• 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/10449188
• 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).

本任务令的目的是为NCI提供的血浆和/或肿瘤样本中假定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。需要迅速扭转局面。在这项任务订单下有一项基本工作和九个备选项。