Preclinical Toxicology of Chemopreventive Agents--WS

化学预防药物的临床前毒理学

• 批准号: 2357666
• 负责人: JOHN G PAGE
• 金额: $ 94.92万
• 依托单位: SOUTHERN RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2357666
• 关键词: Preclinical; Toxicology; Chemopreventive; Agents; WS

The National Cancer institute, Division of Cancer prevention and control, Chemoprevention Branch has initiated an investigational agent development program for chemopreventive agents with potential for inhibiting the process of carcinogenesis. The purpose is to obtain new agents suitable for clinical trials in humans who do not have cancer but may be at increased risk for cancer. Agents being developed by the chemoprevention Branch must be tested for toxicity in animals; all toxicologic data and a summary of toxicity observed in animals treated with the agent must be submitted to the Food and Drug Administration as part of the investigational New Drug Application for human clinical trials. The objective of this project - carcinogenicity Study of Difluoromethyl ornithine (DFMO) in Rats - is to evaluate the potential of DFMO to cause cancer in F344 rats when administered for 104 consecutive weeks.

国家癌症研究所，癌症预防和 控制，化学预防分支已启动一项研究药物 化学预防剂的开发计划， 抑制致癌过程。 目的是获得新的 适用于在未患癌症的人中进行临床试验的药物 但可能会增加患癌症的风险。 正在开发的代理商 化学预防分支必须在动物中进行毒性测试;所有 毒理学数据和给药动物中观察到的毒性总结 与代理人必须提交给食品和药物管理局 作为人类临床研究新药申请的一部分 审判 本项目的目的-致癌性研究 大鼠中的二氟甲基鸟氨酸（DFMO）-旨在评价 在F344大鼠中，当给予104 连续几周。