中药与天然药物非临床药代动力学评价的思考  

Viewpoint on Non-clinical Pharmacokinetic Evaluation of Traditional Chinese Medicine and Natural Medicine

作　　者：韩玲[1] 朱家谷[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：《中国天然药物》2006年第6期473-476,共4页

摘　　要：针对中药、天然药物非临床药代动力学资料中存在的常见问题,从药品技术审评的角度提出相关的认识和看法,分析并阐明了非临床药代动力学研究的目的和基本原则,提出了药代动力学研究中应关注综合分析与评价等内容。希望能对新药研发者在进行药代动力学方法学探索、试验设计、试验实施及结果评价过程中有一定引导作用。Aiming at the common problems found in the data of non-chnical pharmacokinetic studies of traditional Chinese medicine and natural medicine apphed for new drug registration, we present our understandings and opinions from the angle of technical evaluation for drug. In addition, the purpose and the basic principle for non-clinical pharmacokinetic study are analyzed and elucidated, and the suggestions including comprehensive evaluation and analysis in the non-clinical pharmacokinetic study are given. We hope that these would redound to the new method establishment, experimental design and conduction, and result analysis in the study of pharmacokinetics.

关 键 词：中药 天然药物 非临床药代动力学 

分 类 号：R969.1[医药卫生—药理学]