Title |
Criteria Revision and Performance Comparison of Three Methods of Signal Detection Applied to the Spontaneous Reporting Database of a Pharmaceutical Manufacturer
|
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Published in |
Drug Safety, November 2012
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DOI | 10.2165/00002018-200730080-00008 |
Pubmed ID | |
Authors |
Yasuyuki Matsushita, Yasufumi Kuroda, Shinpei Niwa, Satoshi Sonehara, Chikuma Hamada, Isao Yoshimura |
Abstract |
Several statistical methods exist for detecting signals of potential adverse drug reactions in spontaneous reporting databases. However, these signal-detection methods were developed using regulatory databases, which contain a far larger number of adverse event reports than the databases maintained by individual pharmaceutical manufacturers. Furthermore, the composition and quality of the spontaneous reporting databases differ between regulatory agencies and pharmaceutical companies. Thus, the signal-detection criteria proposed for regulatory use are considered to be inappropriate for pharmaceutical industry use without modification. The objective of this study was to revise the criteria for signal detection to make them suitable for use by pharmaceutical manufacturers. |
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Student > Doctoral Student | 3 | 10% |
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Unknown | 4 | 14% |