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Abstract Details
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Activity Number:
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358
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Type:
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Roundtables
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Date/Time:
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Tuesday, July 31, 2012 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305626 |
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Title:
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Developing Standards for Analysis Files: An Update
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Author(s):
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Stephen Wilson*+
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Companies:
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FDA/CDER/OB/DBIII
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, 20993, United States
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Keywords:
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data standards ;
CDISC ;
ADaM ;
statistical review ;
regulatory submissions ;
analysis files
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Abstract:
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Industry-submitted data and meta-data are the "raw materials" needed for the statistical review of NDA/BLA applications. Statisticians from the FDA are currently collaborating with the CDISC/ADaM Team and sponsors in developing standards for the submission of analysis files and appropriate documentation to the Agency. This roundtable will give us the opportunity to discuss the objectives, progress and issues associated with these standardization efforts and how these activities will affect/improve submission and review practices.
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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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