Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL05: Safety Score: Maximizing Information for Decision-Theoretic Approaches (300569)

*Pablo E Bonangelino, FDA/CDRH 

Keywords: safety, benefit-risk, decision analysis

A safety score can provide more coherent information than simpler assessments of safety such as the presence or absence of various categories of adverse events. Such a score could be used as a more informative input to a decision analysis approach. Two specific examples will be discussed.