摘要
《中药、天然药物治疗冠心病心绞痛临床研究指导原则》于2011年7月20日由国家食品药品监督管理局颁布。该适应证的临床研究技术要求得到了质的提高,试验设计更加科学、规范。本文从社会发展、研究与技术审评的需要等方面论述该指导原则的重要性。与2002年的指导原则作了针对性的比较,解读该指导原则的关键技术问题和基本框架,以期研究者能正确理解并执行。
Guideline for Clinical Study on Angina Pectoris of CHD Treated with Traditional Chinese Medicines and Natural Medicines was promulgated by the State Food and Drug Administration on July 20th, 2011.The technical requirements for the clinical trials on angina pectoris were improved substantially and the design of clinical trials was more scientific and standardized. This paper discussed the importance of the guideline in terms of social development and the needs of research and technical evaluation. With the comparison of the previous guideline made in 2002, the critical and technical issues and the basic framework of the newly published guideline were interpreted.
出处
《中国执业药师》
CAS
2012年第3期3-6,共4页
China Licensed Pharmacist
关键词
中药
天然药物
临床研究
指导原则
冠心病心绞痛
Traditional Chinese Medicine
Natural Medicine
Clinical Study
Guideline
Angina Pectorisof CHD
