| アブストラクト | Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small sample size and short follow-up time. The data collected in the postmarketing spontaneous reporting systems such as Food and Drug Administration Adverse Event Reporting System as well as electronic medical record systems provide crucial information to evaluate postmarketing drug safety. In this article, we assess the strengths and limitations of Food and Drug Administration Adverse Event Reporting System and electronic medical record data in studying the postmarketing pharmacovigilance outcomes for 12 selected antidepressant drugs. In addition, we evaluate the consistency of the results obtained from these two data sources, and provide potential directions for evidence integration. |
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| ジャーナル名 | Health informatics journal |
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| 投稿日 | 2019/3/20 |
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| 投稿者 | Duan, Rui; Zhang, Xinyuan; Du, Jingcheng; Huang, Jing; Tao, Cui; Chen, Yong |
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| 組織名 | University of Pennsylvania, USA.;The University of Texas Health Science Center at Houston, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30887861/ |
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