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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 - #310122
Title: Signal Detections in Drug Safety Research
Author(s): Li Zhu*+ and Padmaja Chiruvolu and Maggie Chen and Liying Zhang and Jinyu Yuan and Qi Jiang
Companies: Amgen and Amgen Inc and Assent Consulting and Assent Consulting and Kforce and Amgen
Keywords: Bayesian Confidence Propagation Neural Network ; Bayesian Three-Level Hierarchical Mixture Model ; Double False Discovery Rate ; Multi-Item Gamma Poisson Shrinker ; Proportional Reporting Ratio ; Statistical Method Performance

With the increased regulatory requirements for risk evaluation and minimization strategies, large volumes of comprehensive safety data have been collected and maintained by pharmaceutical sponsors, and proactive evaluation of such safety data has become extremely important during the drug development life-cycle. This presentation will introduce several key statistical methodologies for quantitative safety analysis and signal detection including some recommended by regulatory agencies as well as a few newly developed methodologies. This presentation will summarize technical aspects of each methodology and compare their performance through examples.

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

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