摘要
通过分析目前中药改剂型申请临床方面存在的问题,结合现行法规要求,提出研制者在中药改剂型立题目的与依据、临床试验方面需重点关注的问题。
The problems in changing preparation of traditional Chinese medicine were analyzed. We explained what the researcher should pay attention to, such as item of purpose and gist, and clinical trail technology requirement, combined with the current regulations.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2012年第19期3001-3002,共2页
China Journal of Chinese Materia Medica
关键词
中药
改剂型
临床
技术要求
traditional Chinese medicine
change preparation
clinic
technology requirement
