Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance

doi:10.19803/j.1672-8629.20240471

Abstract

Abstract: Objective To analyze and interpret the READUS-PV standard for drug safety signal detection based on individual safety reports in pharmacovigilance so as to provide references for related research in China. Methods The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in pharmacovigilance (READUS-PV) jointly delivered by experts in pharmacovigilance worldwide was analyzed and interpreted. Results READUS-PV included 14 items concerning the title, introduction, methods, results, discussion, declaration and abstracts. Conclusion In actual drug safety signal detection research, READUS-PV can be consulted to improve research quality.

Key words: Individual Case safety Reports, Pharmacovigilance, Signal Detection, Explanation, Elaboration

CLC Number:

R994.11

LIANG Jizhou, CHEN Chenxin, BAI Wangyang, GUO Xiaojing, XU Jinfang, HE Jia, YE Xiaofei. Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance[J]. Chinese Journal of Pharmacovigilance, 2024, 21(11): 1280-1283.

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