创新性药物临床试验剂量和给药方案的探索和确定  

Discussion on dose and dosage regimen exploring and confirming in new drug clinical trials

作　　者：杨进波[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国临床药理学与治疗学》2008年第8期841-846,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：在创新性药物临床试验中,从最初人体初始剂量的设定到最后确定临床给药剂量和方法是业界普遍关心的问题,也是目前制约我国创新性药物研发水平提升的重要瓶颈之一。本文结合有关文献和具体审评实践,探讨创新性药物临床试验剂量的探索和确定方法。It is generally concerned by industries that some important questions in new drug clinical trials from designing the first dose in human to confirm the last dosage regimen, which is also one of the key bottlenecks to restrict the promotion of new drug research and development in China. Based on some references and review experience, this article is to discuss dose and dosage regimen exploring and confirming in new drug clinical trials.

关 键 词：创新性药物 剂量 探索 确定 

分 类 号：R969[医药卫生—药理学]