Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 313 - Data Analytics and Visualization: Advances and Challenges
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 10:00 AM to 11:50 AM
Sponsor: Section on Statistical Graphics
Abstract #309756
Title: Improved Signal Detection and Evaluation Using New Open-Source Interactive Safety Graphics
Author(s): James Buchanan*
Companies: Covilance LLC
Keywords: signal detection; signal evaluation; safety; drug induced liver injury; interactive graphics; open source

The DIA-ASA Biopharm Safety Evaluation Working Group has developed a novel, open-source, interactive safety graphic tool to enhance the ability of safety professionals to identify and evaluate safety signals. The first tool released is designed to explore cases of potential drug-induced hepatotoxicity based on the eDISH plot developed by FDA. The tool allows the user to dynamically adjust laboratory thresholds to account for disease states with baseline elevated values, modify the time dimension for the occurrence of peak ALT/AST and bilirubin values, account for the extent of alkaline phosphatase elevation, with filters for demographic characteristics. Cases that appear in the potential Hy’s Law, Temple’s corollary and hyperbilirubinemia quadrants can be each be explored to detail the time course of changes in various analytes, assess the cholestatic or hepatocellular characteristics of the case and estimate the extent of hepatocyte loss. A workflow is provided to guide the user through the recommended analyses, using the features of the tool, for each of the quadrants of interest. The workflow is based on evaluations supported by expert hepatologists and the medical literature.

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

Back to the full JSM 2020 program