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• W2023071006 abstract "Abstract Because of rare but serious adverse events, pharmaceutical drugs and vaccines are sometimes withdrawn from the market, either by a government agency such as the Food and Drug Administration (FDA) in the United States or by the manufacturing pharmaceutical company. In other cases, a drug may be generally safe but increase the risk for serious adverse events for certain subpopulations such as pregnant women or people with heart problems. Due to limited sample size and selected study populations, rare adverse events are often impossible to detect during phase 3 trials conducted before the drug is approved for general use. It is then important to conduct post-approval drug safety surveillance, using, for example, health insurance claims data. In such surveillance, the goal should be to detect serious adverse events as early as possible without too many false alarms, and it is then natural to use a continuous or near-continuous sequential test procedure that reevaluates the data on a daily or weekly b..." @default.
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• W2023071006 date "2011-01-21" @default.
• W2023071006 modified "2023-10-15" @default.
• W2023071006 title "A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance" @default.
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• W2023071006 doi "https://doi.org/10.1080/07474946.2011.539924" @default.
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