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