PRECLINICAL PHARMACOLOGY INVESTIGATION/ANTITUMOR AGENTS

临床前药理学研究/抗肿瘤药物

• 批准号: 3616828
• 负责人: KENNETH CHAN
• 金额: $ 19.42万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-04-30 至 1992-04-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3616828
• 关键词: antineoplastics; bioassay; chemical information system; dosage; drug adverse effect; neoplasm /cancer pharmacology; antineoplastics; bioassay; chemical information system; dosage; drug adverse effect; neoplasm /cancer pharmacology

Preclinical pharmacology studies of antitumor agents under development of DTP are conducted under this contract to collect data which will be used to improve both the interpretation of preclinical toxicology data as well as the efficiency of the Phase I trials of new agents. Task Assignments are issued to contractors to perform defined pharmacologic projects. In general these studies are conducted in parallel with or prior to preclinical toxicology evaluations of the experimental agents. It is the expectation that from these studies will come assays of antitumor agents of sufficient sensitivity to be used in the clinic. Further studies will be designed to investigate the pharmacokinetics of the drug after bolus and infusion dosing in mice, rats and/or dogs. A major objective of this project is the collection of data which will ultimately lead to an understanding of species differences so that a significant reduction in the number of doses may result in the dose escalation schemes employed in Phase I clinical trials. The pharmacological information obtained through the Task Orders will play a potentially greater role in the drug development process in the future because of the increasing emphasis on in vitro screens which is contemplated in the next several years. Basic pharmacokinetic data will contribute to the planning of treatment regimens and when significant species differences are observed preclinically, the Phase I clinician is alerted to their potential human significance.

抗肿瘤剂的临床前药理学研究 DTP的开发是根据本合同进行的 将用于改善解释的数据 临床前毒理学数据以及阶段的效率 我试用新代理商。 任务分配发给承包商 执行确定的药理项目。 通常，这些 研究是与临床前或之前的 实验剂的毒理学评估。 是 期望从这些研究中进行抗肿瘤的测定 在诊所中使用的足够灵敏度的药物。 更远 研究将旨在研究研究的药代动力学 大鼠，大鼠和/或狗的推注和输注给药后的药物。 该项目的主要目的是数据集合 最终将导致对物种差异的理解 剂量数量的显着减少可能导致 在I期临床试验中采用的剂量升级方案。 通过任务订单获得的药理信息 将在药物开发中发挥潜在的作用 未来的过程由于越来越强调 未来几年将考虑的体外屏幕。 基本的药代动力学数据将有助于计划 治疗方案以及重大物种差异是 从临床上观察到，第一阶段临床医生被警告 潜在的人类意义。