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Activity Number:
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152
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Type:
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Roundtables
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Date/Time:
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Monday, August 4, 2008 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301153 |
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Title:
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Design and Analysis of Medical Device Clinical Studies for Purposes of FDA Marketing Approval
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Author(s):
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Gary Kamer*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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1350 Piccard Drive, Suite 100, (HFZ-550), Rockville, MD, 20850,
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Keywords:
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study design ; statistical analysis ; public health ; regulatory setting
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Abstract:
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Certain study designs and statistical analyses may be either unique to or more commonly used in a public health regulatory setting (such as FDA) than in other research situations. This session will provide an opportunity to identify and discuss not only these methods, but the reasons for their use. Several topics may be suggested by the roundtable leader, but discussion resulting from actual participant experiences will prove most beneficial.
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