Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases

Abstract

Abstract: Pharmacoepidemiologic studies play an important role in evaluating the interrelationship between drugs and adverse events. With the development of the electronic healthcare databases, the traditional method of pharmacoepidemiologic study cannot completely meet the needs of the pharmacovigilance today. Based on the understanding of the electronic healthcare databases and of the FDA related guidelines, this paper proposes to introduce the general characteristics of pharmacoepidemiologic safety studies using electronic healthcare databases and the requirements of the data collection put forward by FDA, which aims to provide relevant technical reference to our country's pharmacoepidemiologic studies and pharmacovigilance.

Key words: pharmacoepidemiologic safety studies, electronic healthcare databases, pharmacovigilance

CLC Number:

R994.11

ZHU Tian-tian, YE Xiao-fei, GUO Xiao-jing, ZHANG Tian-yi, WANG Jing, SHI Wen-tao, HE Jia. Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases[J]. Chinese Journal of Pharmacovigilance, 2014, 11(7): 413-315.

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