陆国才新药临床前毒理学评价.ppt

Contents 目的意义 急性毒性试验(acute) 长期毒性试验(chronic) 特殊毒性试验(遗传、生殖、致癌) 其它毒性试验(过敏、刺激 etc.) 药物非临床研究质量管理规范（GLP） SFDA新药审评会 案例学习 目的意义 新药评价的核心内容 确保临床用药安全 ＞限量、改变途径?有毒 Toxicity—Everywhere 1274宋慈指出万物皆毒 CA化学品约一千万, USA每年上市新化学品1500种左右 1992年联合国环境与发展大会：有毒化学品?21st(1/7)环境问题 Drug Hazards The COX-2 Hypothesis (1992) “Merck pulls popular pain drug due to risks of heart attacks” Risk of Serious CV Events of Celecoxib* Dear FDA: When I was 6 years old, I had fun … … All of that ended when I came home from the first grade, not feeling very well. My parents gave me Childrens Motrin, but instead of getting