Pharmacokinetic and Pharmacological Studies of Antitumor and other Therapeutic Agents

抗肿瘤和其他治疗药物的药代动力学和药理学研究

• 批准号: 9035201
• 负责人: JULIE L. EISEMAN
• 金额: $ 7.68万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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/9035201
• 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; 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NCI癌症治疗部选择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。根据本合同选择的候选疗法来自学术研究者、制药公司或其他人提交给NCI的同行评审申请。根据合同开展的工作包括：（1）开发分析方法，以量化生物基质中测试剂的水平;（2）血浆稳定性和蛋白质结合研究;（3）通过各种途径和时间表给药后的药代动力学特征;（4）量化和鉴定产生的代谢物;和（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剂水平和/或总暴露的相关性。从这些药代动力学研究中获得的表征用于进一步开发药物的优先级排序和选择;用于临床前疗效和毒理学研究的设计以及用于支持选定药物临床试验的法规提交。