CHRONIC ORAL TOXICITY STUDIES OF BOWMAN/BIRK INHIBITOR

癌症预防与治疗部化学预防分支 国家癌症研究所的控制中心指导了一个项目， 开发人类使用的药物，以预防，延迟或逆转 细胞发育不良（例如上皮内瘤变）进展至 侵袭性癌症 药物研发过程的一部分 涉及临床前毒理学研究。 进行这些研究 根据已发布的指南文件，遵循药物非临床研究质量管理规范 由食品和药物管理局，并用于支持 研究性新药申请和最终新药申请 申请癌症化学预防剂的上市许可 承包商应进行为期6个月的小鼠口服毒性研究， 12-在犬中进行的大豆衍生化合物Bowman- Birke抑制剂。 终点应包括临床和解剖病理学 特别注意胰腺。

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.