Adverse Drug Reactions

Research on adverse drug reactions published by scientists at Harvard University

Published in Vaccine Weekly, March 3rd, 2010

According to a study from the United States, "The importance of post-marketing surveillance for drug and vaccine safety is well recognized as rare but serious adverse events may not be detected in pre-approval clinical trials. In such surveillance, a sequential test is preferable, in order to detect potential problems as soon as possible."

"Various sequential probability ratio tests (SPRT) have been applied in near real-time vaccine and drug safety surveillance, including Wald's classical SPRT with a single alternative and the Poisson-based maximized SPRT (MaxSPRT) with a composite alternative. These methods require that the expected number of events under the null...

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Source: Vaccine Weekly (2010-03-03)

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