DIA 48th Annual Meeting
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NDA/BLA Statistical Review and the CDISC ADaM Data Standards
Track : Track 15: Statistical Science and Quantitative Thinking
Program Code: 214
Date: Tuesday, June 26, 2012
Time: 8:00 AM to 9:30 AM  EST
 Stephen Wilson, FDA, United States
 Behrang Vali, FDA, United States
James Johnson, UCB BioSciences Inc., United States
 Michael Nessly, Shire Specialty Pharmaceuticals, United States
This forum will describe the receipt and statistical review of analysis files based on the ADaM standards at the Center for Drug Evaluation and Research. The panel will discuss problems and potential improvements

Learning Objectives:
Describe the experience with the receipt and review of ADaM-based analysis files by CDER statisticians
Identify areas of improvement for ADaM standards and review processes and tools.