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Abstract Details
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Activity Number:
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325
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304523 |
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Title:
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Validation of Prognostic Biomarker in a Regulatory Submission: A Science-Based Approach
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Author(s):
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Rong Tang*+ and Gene Pennello
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Companies:
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FDA and FDA
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, , United States
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Keywords:
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prognostic marker ;
validation ;
study design ;
analysis
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Abstract:
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The number of prognostic markers that have been successfully validated in a regulatory submission is relatively small compared to the amount of research and publications in this area. In order to demonstrate the prognostic utility of a biomarker, the validation study needs to have an appropriate design and contain several key analyses. We plan to look through the history of regulatory approval of prognostic biomarkers and discuss some critical statistical issues in the validation of a prognostic biomarker in a regulatory submission.
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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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