抗肝癌中成药研发风险动态监控  

Dynamic monitoring risk of anti-hepatoma new drug development

作　　者：张靖[1] 樊威[2] 李红法[1] 满淑丽[2] 刘振[1] 高文远[1] 

机构地区：[1]天津大学药物科学与技术学院,天津300072 [2]天津科技大学生物工程学院,天津300457

出　　处：《中国中药杂志》2014年第20期4050-4053,共4页China Journal of Chinese Materia Medica

摘　　要：抗肝癌中成药新药风险监控就是追踪已经识别的风险、监测残余的风险,识别新出现的风险、确保风险计划的实施,评估其降低风险有效性的过程。该文主要通过深入了解抗肝癌中成药现状、风险动态监控的内涵、特征及风险监控体系的分析方法,进而选择风险监控指标,进行风险信息的搜集,提出对建立我国抗肝癌中成药新药上市后风险再评价的思考,最后尝试建立抗肝癌中成药新药风险动态管理模式。Risk monitoring of new Chinese patent anti-hepatoma drugs is tracking recognized risks and residual risks, identifying emerging risk and ensure the implementation of the plan, estimating the process of reducing effectiveness. The paper is mainly through understanding the status of Chinese patent anti-hepatoma drugs,the content, characteristic and analysis method of dynamic risk monitoring, and then select the risk control indicators, collect risk information. Finally, puts forward the thought of anti-hepatoma drugs listed evaluation in our country, and try to establish the model of dynamic risk management of anti-hepatoma drugs.

关 键 词：抗肝癌中成药新药 风险 动态监控 

分 类 号：R288[医药卫生—中药学]