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Abstract Details
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Activity Number:
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484
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Type:
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Invited
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Health Policy Statistics
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| Abstract - #300434 |
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Title:
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Safety Graphics: Graphical Approaches for Identifying Safety Signals
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Author(s):
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Janelle Charles*+
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Companies:
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U.S. Food and Drug Administration/OTS/CDER
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Address:
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Division of Biometrics VII, Silver Spring, 20993,
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Keywords:
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safety ;
graphics
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Abstract:
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Currently most statistical summaries of safety information from clinical trials are displayed in lengthy tables or listings. It is challenging for both reviewers and decision makers to use these presentations to quickly identify safety signals, to adequately characterize the safety profile of pharmaceutical products in the context of their intended indication, and ultimately to make decisions regarding benefit-risk. The purpose of this presentation is to investigate a set of graphics that aid safety experts in identifying and evaluating safety information more effectively and efficiently.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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