Abstract Details
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Activity Number:
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280
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313010
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View Presentation
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Title:
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Statistical Analyses Using Standardized Data: Anti-Viral Experience
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Author(s):
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Wen Zeng*+
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Companies:
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FDA/CDER
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Keywords:
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ADaM ;
Anti-Viral ;
Analysis Datasets
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Abstract:
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The Anti-viral statistics team at the FDA has used standardized clinical trial data during the NDA review process. In this talk, the experiences of the team will be shared. We will also discuss additional analysis datasets that are requested as well as prospective recommendations for future NDAs that will facilitate the review process.
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Authors who are presenting talks have a * after their name.
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