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Abstract Details
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Activity Number:
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37
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Type:
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Contributed
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302448 |
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Title:
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Estimation of the Adverse-Events Warning Signal Through the Historical Event Rate
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Author(s):
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Qian F. Graves*+ and Peng Tu Liu and Stuart Chirtel
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration
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Address:
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5100 Paint Branch PKWY, College Park, MD, 20740,
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Keywords:
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Background Rate ;
Historical Control ;
Drug-Event Association ;
Signal Analysis
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Abstract:
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Based on the many hundreds of thousands of relevant cases reported in the Adverse Events Reporting System (AERS), we can establish the "historical" rate for each adverse event. For any given "drug-event signal" can be defined by a ratio of an event rate for the specific drug to the corresponding historical event rate. Use of this approach involving the historical rate as a reference standard could greatly simplify and facilitate in the data procession, in parameter estimation, in signal ranking, in priority setting, in sequential testing and in program monitoring.
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