THIRTEEN WEEK ORAL TOXICITY STUDY OF P-XSC IN DOGS

P-XSC 在狗中为期十三周的口服毒性研究

• 批准号: 2829285
• 负责人: JOHN G PAGE
• 金额: $ 5.73万
• 依托单位: SOUTHERN RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 1999-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2829285
• 关键词: cancer prevention; chemoprevention; cyanate; dogs; drug hypersensitivity; drug screening /evaluation; selenium; thrombocytopenia; toxicant screening

The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Caner 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 applications and eventually New Drug Applications to the marketing approval of cancer chemopreventive agents. The contractor shall conduct a 13-week toxicity study of 1,4- Phenylenebis(methylene) selenocyanate in dogs. In a previous study of this compound thrombocytopenia was observed. This study is designed to evaluate the mechanism of this effect and to test the hypothesis that it is based on a drug-induced immune response.

癌症预防和化学预防司 国家癌症研究所的控制部门指导一项计划来识别和 开发供人类使用的药物，以预防、延迟或逆转疾病 细胞发育不良（例如上皮内瘤变）进展为 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。 这些研究进行 根据已发布的指导文件，符合良好实验室规范 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 癌症化学预防剂的上市批准。 承包商应对 1,4- 进行为期 13 周的毒性研究 亚苯基二（亚甲基）硒氰酸盐在狗中的应用。 在之前的一项研究中 观察到这种复合性血小板减少症。 这项研究旨在 评估这种效应的机制并检验它的假设 基于药物诱导的免疫反应。