Abstract:
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The statistical methods used for data-mining or signal detection of drug-adverse event combinations from large drug safety databases such as FDA's Adverse Event Reporting System (FAERS), consisting of spontaneous reports on adverse events for post-market drugs are called passive surveillance methods. On the other hand, the statistical signal detection methods for longitudinal data, as the data accrues in time, are called active surveillance methods. A review of the most commonly used passive surveillance statistical methods, along with the likelihood ratio test (LRT) based methods, will be discussed in detail.
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