指导原则解读系列专题(六) 仿制药品处方与工艺研究  

The formula development and manufacturing processing research in generic drug

作　　者：魏农农[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：《中国新药杂志》2009年第2期105-107,共3页Chinese Journal of New Drugs

摘　　要：处方与工艺研究是仿制药品研发的重点之一,国内外相应指导原则对仿制药品处方与工艺都有相关指导原则予以阐述。众所周知,处方与工艺直接关系产品的质量、稳定性,也可能对产品的安全性和有效性产生影响。现结合相关指导原则,对仿制药品的处方和工艺研究的思路进行了探讨。The formula development and manufacturing processing research is always one of important parts in generic drug. The international guidelines and regional guidance have illustrated formula development and processing research of generic drug . As we all known, formula and processing research effects drug products quality and stability, and also influences safety and efficacy. In this article, the method of formula development and processing research has overviewed in generic drug.

关 键 词：仿制药品 处方研究 工艺研究 

分 类 号：R925[医药卫生—药学]