SEGMENT II TERATOLOGY STUDIES

癌症预防和预防司化学预防处 国家中心研究所的控制中心指导一个项目来识别和 开发人类使用的药物，以防止、延缓或逆转 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。 承包商应完成四(4)个发育、畸形学部分 II在授予合同的2年内对大鼠和兔进行评估。 要评估的化合物将由NCI指定。一次测距 并对每一物种进行一次确定的测试。评估 应包括物质和胎儿毒性以及内脏和骨骼 胎儿畸形。

The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Center Institute directs a program to identify and develop drugs for human use that will prevent, delay, or reverse the 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 application and eventually New Drug Applications to the FDA for the marketing approval of cancer chemopreventive agents. The contractor shall complete four (4) developmental, teratology Segment II evaluations in both rats and rabbits within 2 years of contract award. The compound to e evaluated will be specified by the NCI. A range finding and a definitive test shall be conducted for each species. Evaluation shall include material and fetal toxicities and visceral and skeletal fetal malformations.