Expert consensus on quantitative analysis of cytokines in clinical trials(2024 version)
Cytokines are important signaling molecules in various tissues and cells,and have become indispensable study content for pharmacodynamics evaluation and safety monitoring in clinical trials.In view of the current situation that quantitative analysis of cytokines in clinical trials is facing multiple problems and challenges,the Pharmaceutical Biological analysis Professional Committee of the Chinese Pharmaceutical Association organized experts to conduct in-depth discussions.This article elaborates on the characteristics of quantitative detection techniques systematically,and analyzes the differents between measurements.An expert consensus has been reached on the general principles of quantitative analysis of cytokines in clinical trials,covering the selection of analysis platforms,the requirements of bioanalytical method validation,and the influencing factors on biological samples,aiming to provide reference for the scientific and standardized conduct of such research.
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