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Considerations for Identification of Drug-Induced Liver Injury
Session Chair(s)
James Buchanan, PharmD
President
Covilance LLC, United States
Identification of drug-induced liver injury (DILI) is hindered by the lack of a structured, standardized approach to its identification and evaluation. This leads to inefficiencies for both sponsors and regulators. Guidance related to data submission for DILI evaluation can improve the efficiency of regulatory review, for example, by reducing the number of information requests sent by the FDA to industry sponsors. Ultimately, improved strategies for DILI data gathering and submission will also improve the accuracy of DILI risk assessment. This session will provide an in-depth discussion of the challenges for reviewing clinical data and suggest potential strategies to improve the DILI identification process. Topics that will be covered include (1) regulatory guidance on structured DILI data submission, (2) how interactive data visualizations tools can enhance the ability to detect potential cases of DILI and (3) the approach to populations with elevated transaminases at baseline and why the modified eDISH (mDISH) approach has important limitations.
Learning Objective : Describe the regulatory guidance for how to submit structured data pertaining to drug-induced liver injury (DILI) data; Discuss how to utilize interactive visualization tools to identify potential cases of DILI; Identify the challenges for detecting DILI when liver tests are abnormal at baseline.
Speaker(s)
Regulatory Guidances for Submitting Structured DILI Data
Y. Veronica Pei, MD, MEd, MPH
FDA, United States
Acting Associate Director, Biomedical Informatics and Regulatory Review Science
Use of Interactive Visualization Tools to Identify Potential Cases of DILI
James Buchanan, PharmD
Covilance LLC, United States
President
Addressing the Challenges of DILI Detection in Clinical Trials with Abnormal Baseline Liver Tests
Paul Hayashi, MD, MPH
FDA, United States
Associate Director of DILI, Division of Hepatology and Nutrition, OND, CDER
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