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Activity Number: 32
Type: Contributed
Date/Time: Sunday, August 4, 2013 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309891
Title: Statistical Methods Used in Safety Evaluation for NDA Submissions
Author(s): Linyun Zhou*+
Companies: Takeda Global Research & Development
Keywords: rare event ; relative risk ; exact method ; hazard ratio ; time-to-event ; re-current events

For a clinical trial data analysis, it is always a challenge to detect or rule out potential safety issues based on limited trials data, such as limited exposure time/duration, limited sample size, or potential bias introduced by experimental design. Some analysis methods for safety evaluation in multiple approved NDA submissions are introduced. To address some potential safety signals, relative risk and hazard ratio for rare events with exact method are applied. The analyses are based on integrated large safety database.

Authors who are presenting talks have a * after their name.

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