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Activity Number: 614 - Reasonable Possibility - Statistical Science of Safety Monitoring
Type: Topic Contributed
Date/Time: Thursday, August 2, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329464 Presentation
Title: Visual Analytics to Assess Reasonable Possibility: Using DILI as an Example
Author(s): Kefei Zhou* and Melvin Munsaka and Krishan P. Singh
Companies: Theravance Biopharma and AbbVie, Inc. and GlaxoSmithKline
Keywords: Visual Analitics; DILI; Drug Safety

It is well recognized in that visual analytics present a useful alternative to tabular outputs for exploring safety data and present a great opportunity to enhance the evaluation of drug safety. Graphical depictions of safety data also play a big role in facilitating communication of safety results with regulators, investigators, DMC, and other stakeholders and help convey multiple pieces of information concisely and more effectively than tables. For certain adverse events of special interest (AESI), there is a certain well established set of graphical tools that can help in addressing safety-related questions associated with that AESI as it related to drug product being studied. In this discussion, we will consider the role of visual analytics in assessing an AESI with a focus on drug-induced liver injury (DILI), a major concern in drug development. We will show through some examples using simulated data how visual analytics can play a critical role in the analysis and possible causality of DILI.

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

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