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T-09: Structure and Target Based Statistical Tools for Safety Analysis





Poster Presenter

      Samir Lababidi

      • Statistician
      • FDA
        United States

Objectives

Using statistical tools, the Global Substance Registration System allows analysis of safety data based on a variety of structural parameters, classification systems and both on-target and off-target interactions.

Method

Databases associated with the Global Substance Registration System, R Package and Shiny Applications, together with statistical tools, incorporate regression modeling and machine learning methods

Results

Statistical tools applications provide statistical analysis and safety signal prediction of adverse events

Conclusion

A web interface for analyzing adverse event data in the Global Substance Registration System

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