13 WEEK ORAL TOXICITY STUDIES OF TWO CHEMOPREVENTIVES

两种化学预防药物的 13 周口服毒性研究

• 批准号: 2302648
• 负责人: DAVID L. MCCORMICK
• 金额: $ 48.99万
• 依托单位: IIT RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2302648
• 关键词: 13; WEEK; ORAL; TOXICITY; STUDIES

The National Cancer Institute, Division of Cancer Prevention and Control oversees 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 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 FDA as part of an Investigational New Drug Application for human clinical trials. Thirteen Week Oral Toxicity Studies of Two Chemopreventive Agents To-Be- Named in Rats and Dogs: The protocols fulfill current industry standards for toxicology studies supporting IND applications and guidelines stated in the FDA Redbook. The protocols include observations of plasma drug levels, pharmacological & toxicological clinical observations, food consumption, weight gain, neurology, ophthalmology, cardiology, teratology, and clinical & anatomic pathology. The studies are conducted under FDA GLP. Laboratories are AAALAC accredited, NIH/OPRR & USDA registered, and have active an IACUC.

国家癌症研究所，癌症预防和控制部 监督化学预防的研究药物开发计划 具有抑制致癌过程潜力的药剂。 的 目的是获得适合于在人中进行临床试验的新药剂， 没有癌症，但患癌症的风险可能会增加。 剂为 必须在动物中进行毒性试验;所有毒理学数据和 必须总结用该试剂处理的动物中观察到的毒性， 作为研究性新药申请的一部分提交给FDA 用于人体临床试验 两种化学预防剂的13周口服毒性研究 以大鼠和犬命名：协议符合当前行业标准 用于支持IND申请的毒理学研究和指南 在FDA的红皮书里 方案包括观察血浆药物浓度， 水平、药理学和毒理学临床观察、食物 消耗，体重增加，神经病学，眼科，心脏病学， 畸形学和临床与解剖病理学。 这些研究是在 符合FDA GLP。 实验室获得AAALAC认证，NIH/OPRR和USDA 注册，并有一个活跃的IACUC。