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[Discussion on reference sample research of traditional Chinese medicine compound preparations developed from
Xiao-Xia Zhao1, Chang-Ming Yang1, Wei Han1
1State Key Laboratory of Drug Regulatory Science,Center for Drug Evaluation,National Medical Products Administration Beijing 100076,China.
Abstract:
The concept of reference sample was put forward in the Guidance on CMC of Traditional Chinese Medicine Compound Preparations Developed from Catalogued Ancient Classical Prescriptions(Interim). The research on reference sample is a key link in the research and development of traditional Chinese medicine(TCM) compound prescriptions from catalogued ancient classical prescriptions(known as Category 3.1 TCM). This paper discusses the content of research on reference sample by analyzing the characteristics of Category 3.1 TCM and the purpose of research on reference sample. Furthermore, suggestions on the research of reference sample are proposed according to the development and evaluation practice of Category 3.1 TCM and research achievements of TCM regulatory science, aiming to provide reference for colleagues in this industry.
