Pesudoallergic reactions during post-marketing non-clinical safety reevaluation of traditional Chinese medicine injections

doi:10.19803/j.1672-8629.2022.02.15

Abstract

Abstract: Objective To advise on post-marketing non-clinical safety evaluation of traditional Chinese medicine injection TCMI. Methods The importance of post marketing non clinical safety reevaluation of TCMI was highlighted while the main problems and causes were discussed. Based on the related research by the author's team and focusing on pesudoallergic reactions which were the main ADR of TCMI, this paper elaborated on ways to establish a post-marketing non-clinical safety re-evaluation technical system of TCMI in terms of detection, risk control and prevention of pseudoallergic reactions. Results and Conclusion It is of special importance to identify the major problems with each type of TCMI, analyze the all the factors related to these problems, systematically design the post-marketing safety research scheme, and innovate the ideas and methodology of research.

Key words: traditional Chinese medicine injection, adverse drug reactions/event, non-clinical safety re-evaluation, pesudoallergic reaction

CLC Number:

R994.11

YI Yan, TIAN Jingzhuo, LI Chunying, ZHAO Yong, LIANG Aihua. Pesudoallergic reactions during post-marketing non-clinical safety reevaluation of traditional Chinese medicine injections[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 185-188.

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