Preclinical Pharmacokinetic and Pharmacological Studies of Antitumor and other Th

抗肿瘤等药物的临床前药代动力学和药理学研究

• 批准号: 9113402
• 负责人: JOEL REID
• 金额: $ 7.66万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9113402
• 关键词: Award; Biological; Clinical Trials; Contracts; Development; Drug Kinetics; Investigation; Peer Review; Pharmacodynamics; Pharmacologic Substance; Pharmacology; Plasma; Process; Protein Binding; Research Personnel; Resources; Route; Schedule; Testing; Therapeutic Agents; Tissues; Toxicology; Work; analytical method; cancer therapy; design; metabolic abnormality assessment; pre-clinical; preclinical efficacy; tumor

This contract provides a resource for conducting nonclinical pharmacology, pharmacokinetic, and metabolism studies with candidate therapeutic agents selected for development by the Division of Cancer Treatment, NCI. Candidate therapies selected for study under this contract arise from peer-reviewed applications submitted to NCI by academic investigators, pharmaceutical companies, or others. Work carried out under the contract includes: (1) development of analytical methods to quantify the levels of test agents in biological matrices; (2) plasma stability and protein binding studies; (3) pharmacokinetic characterization following administration by various routes and schedules; (4) quantification and identification of metabolites generated; and (5) assessment of pharmacodynamic effects in tumor or surrogate tissues and correlation of these effects with levels of agent and/or total exposures. The characterizations obtained from these pharmacokinetic investigations are used in the prioritization and selection of agents for further development; in the design of preclinical efficacy and toxicology studies and in regulatory submissions in support of clinical trials of selected agents.

该合同为使用 NCI 癌症治疗部门选择开发的候选治疗药物进行非临床药理学、药代动力学和代谢研究提供了资源。根据本合同选择用于研究的候选疗法来自学术研究人员、制药公司或其他机构提交给 NCI 的同行评审申请。根据合同开展的工作包括：(1) 开发量化生物基质中测试剂水平的分析方法； (2)血浆稳定性和蛋白结合研究； (3) 通过不同途径和时间表给药后的药代动力学特征； (4) 产生的代谢物的定量和鉴定； (5)评估肿瘤或替代组织中的药效学效应以及这些效应与药物水平和/或总暴露量的相关性。从这些药代动力学研究中获得的特征用于确定药物的优先顺序和选择以供进一步开发；设计临床前功效和毒理学研究以及支持选定药物临床试验的监管提交。