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Adverse Drug Reactions

Study findings from Johnson & Johnson broaden understanding of adverse drug reactions

Published in Healthcare Finance, Tax and Law Weekly, September 3rd, 2008

According to recent research published in the American Journal of Public Health, "Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed."

"Systems for assessment of postmarketing adverse events include spontaneous reports, computerized claims or medical record data-bases, and formal postmarketing studies. We briefly review the strengths and limitations of each. Postmarketing...

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