Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer.

@article{Matsushita2007CriteriaRA,
  title={Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer.},
  author={Y. Matsushita and Yasufumi Kuroda and Shinpei Niwa and Satoshi Sonehara and Chikuma Hamada and Isao Yoshimura},
  journal={Drug safety},
  year={2007},
  volume={30 8},
  pages={
          715-26
        }
}
BACKGROUND AND OBJECTIVE 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… CONTINUE READING

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