CHRONIC ORAL TOXICITY STUDIES OF BOWMAN/BIRK INHIBITOR

癌症预防和预防司化学预防处 国家癌症研究所的控制中心指导了一项计划，以识别和 开发人类使用的药物，以防止、延迟或逆转 细胞异型增生(如上皮内瘤变)进展为 浸润性癌症。药物研发过程的一部分 涉及临床前毒理学研究。这些研究是进行的 根据发布的指导文件，遵循良好的实验室操作规范 由食品和药物管理局提供，用于支持 研究中的新药申请和最终的新药申请 向FDA申请癌症化学预防药物的上市批准。 承包商应在小鼠身上进行为期6个月的经口毒性研究 大豆衍生化合物鲍曼对狗的12个月经口毒性研究 伯克抑制剂。终点应包括临床和解剖病理学。 尤其要注意胰腺。

The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Cancer Institute directs a program to identify and develop drugs for human use that will prevent, delay, or reverse th progression of cellular dysplasia (e.g. intraepithelial neoplasia) to invasive cancer. Part of the drug research and development process involves preclinical toxicology studies. These studies are performed under Good Laboratory Practices according to guidance documents published by the Food and Drug Administration and are used to support Investigational New Drug applications and eventually New Drug Applications to the FDA for the marketing approval of cancer chemopreventive agents. The contractor shall conduct a 6-month oral toxicity study in mice and a 12-month oral toxicity study in dogs of the soy-derived compound Bowman- Birke Inhibitor. Endpoints shall include clinical and anatomic pathology with particular attention to the pancreas.