IGF::OT::IGF KICK OFF MEETING, PRECLINICAL PHARMACOKINETIC & PHARMACOLOGICAL EVALUATIONS OF AGENTS BEING DEVELOPED FOR CANCER PATIENTS 7/1/2016 - 9/30/16, HHSN261201600020I

该合同是IDIQ多个奖项池的一部分，该奖项池为NCI癌症治疗部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。根据合同进行的工作包括：(1)开发分析方法，以量化生物基质中测试剂的水平；(2)血浆稳定性和蛋白结合研究；(3)不同给药途径和时间给药后的药代动力学特征；(4)产生的代谢物的定量鉴定；(5)评估肿瘤或替代组织的药效学效应，以及这些效应与制剂和/或总暴露水平的相关性。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，以及在支持选定药物临床试验的监管提交中。

This contract is part of an IDIQ multiple award pool which 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.