Analyses & Displays for Hepatotoxicity
Project Description |
This project produces two white papers providing recommendations for analyses and displays to assess hepatotoxicity in Phase II to IV clinical trials and integrated submissions. Stage 1 focuses on a standardised set of analyses and outputs to evaluate whether there is reasonable medical evidence to rule out potential drug-induced liver injury (DILI). Stage 2 addresses situations where DILI cannot be excluded, outlining additional analyses needed to further characterise the safety signal and assess causality. The project aims to improve consistency, transparency and efficiency in hepatotoxicity evaluation across the industry. As a value add, the team will also develop an open-source Hepatotox tool to support the generation of recommended analyses and outputs for both stages. This will enable practical implementation of the guidance and support more robust and reproducible safety assessments. |
Project Leads | |
|---|---|
Melvin Munsaka, AbbVie | |
Terry Walsh, (Volunteer) | |
Nicola Newton, PHUSE Project Coordinator |
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