PRECLINICAL TOXICOLOGY - SEGMENT II TERATOLOGY STUDIES O

临床前毒理学 - 第二部分畸形学研究 O

• 批准号: 6212358
• 负责人: DAVID L. MCCORMICK
• 金额: --
• 依托单位: IIT RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6212358
• 关键词: cancer prevention; chemoprevention; drug adverse effect; drug screening /evaluation; embryo /fetus toxicology; laboratory rabbit; laboratory rat; teratogens; toxicology

The investigator will evaluate 4 possible cancer preventive compounds in rats and rabbits for effects on organogenesis. Rangefinding and definitive tests will be performed to evaluate soft tissue and skeletal malformations as well as maternal toxicity, litter number and sex, gross malformations and other endpoints per the UAFDA-ICH Guideline on Detection of Toxicity to Reproduction for Medicinal products. The studies will be conducted under GLP for submission to the FDA.

研究者将在大鼠和家兔中评价4种可能的癌症预防化合物对器官发生的影响。根据UAFDA-ICH药品生殖毒性检测指导原则，将进行范围探索和确定性试验，以评价软组织和骨骼畸形以及母体毒性、窝仔数和性别、大体畸形和其他终点。 研究将按照GLP进行，以提交给FDA。