| アブストラクト | The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products. Various SRS are employed globally, such as the Food and Drug Administration Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase. In the pharmacovigilance literature, numerous methods have been proposed to assess product-adverse event pairs for potential signals. In this paper, we introduce an R and Python package that implements a novel pattern discovery method for postmarketing adverse event identification, named Modified Detecting Deviating Cells (MDDC). The package also includes a data generation function that considers adverse events as groups, as well as additional utility functions. We illustrate the usage of the package through the analysis of real datasets derived from the FAERS database. |
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| 組織名 | Department of Biostatistics, University at Buffalo, Buffalo, NY, 14214, USA.;CDSE Program, University at Buffalo, Buffalo, NY, 14260, USA.;markatou@buffalo.edu.;Department of Medicine, Jacobs School of Medicine and Biomedical Sciences,;University at Buffalo, Buffalo, NY, 14203, USA. markatou@buffalo.edu. |
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