摘要
目的为进一步提高我国药品技术监管水平提供参考。方法介绍国外的药品评价方式及技术,分析我国评价技术中存在的不足。结果与结论提出未来相关技术监管工作发展方向的建议,即加强原料、辅料、处方、工艺的研究,完善溶出度检测方法。
Objective To provide references for further enhancing in China. Methods Foreign evaluation methods and techniques were domestic technical evaluation were analyzed. Results and Conclusion improvement trend of technical supervision in the future, i.e., excipients and prescription and process should be strengthened, and improved as well. drug technological supervision level introduced. And the deficiencies of Suggestions were proposed on the the research on crude materials, the dissolution methods need to beimproved as well.
出处
《中国药事》
CAS
2013年第10期1018-1020,1024,共4页
Chinese Pharmaceutical Affairs
关键词
仿制药
一致性评价
口服固体制剂
溶出度试验
generic drug
consistency evaluation
oral solid preparation
dissolution test
