13 WEEK ORAL TOXICITY STUDIES OF TWO CHEMOPREVENTIVES

国家癌症研究所，癌症预防和控制部 监督化学预防的研究试剂开发计划 有可能抑制致癌过程的药物。这个 目的是获得适用于人类临床试验的新药物 没有患癌症，但患癌症的风险可能会增加。代理是 必须对研制的药物进行动物毒性测试；所有毒理学数据和 在使用该制剂治疗的动物身上观察到的毒性总结必须是 作为调查新药申请的一部分提交给FDA 用于人体临床试验。 两种化学防腐剂13周口服毒性研究 以老鼠和狗命名：该协议符合当前的行业标准 关于支持IND申请和指南的毒理学研究 在FDA红皮书中。这些方案包括观察血浆药物 水平、药理和毒理学临床观察、食品 消耗，体重增加，神经科，眼科，心脏科， 畸形学、临床和解剖病理学。这些研究是在 在FDA GLP下。实验室是AAALAC认证的，NIH/OPRR和USDA 注册，并已激活IACUC。

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.