Preclinical Pharmacokinetic and Pharmacological Studies of Antitumor and other Th

该合同为NCI癌症治疗部选择开发的候选治疗药物进行临床前药理学、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者、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)开发分析方法，以量化血浆、尿液和其他生物基质中测试剂的水平；(2)血浆稳定性和蛋白结合研究；(3)药代动力学表征；(4)代谢物的定量鉴定；(5)药效学效应评价。从这些药代动力学研究中获得的特征用于进一步开发的药物的优先级和选择；在临床前疗效和毒理学研究的设计中，或在支持选定药物临床试验的监管意见书中。

This contract provides a resource for conducting preclinical 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 plasma, urine, and other biological matrices; (2) plasma stability and protein binding studies; (3) pharmacokinetic characterization; (4) quantification and identification of metabolites; and (5) assessment of pharmacodynamic effects. The characterizations obtained from these pharmacokinetic investigations were used in the prioritization and selection of agents for further development; in the design of preclinical efficacy and toxicology studies or in regulatory submissions in support of clinical trials of selected agents.