Analyses & Displays for Hepatotoxicity

Project Scope 

This project team will create two white papers with recommendations for analyses and displays associated with hepatotoxicity, with a focus on Phase II to IV clinical trials and integrated submission documents as follows:

•  Stage 1 White Paper: Set of analyses/outputs with reasonable medical probability to rule out potential DILI

• Stage 2 White Paper (potential DILI has not been ruled out): Additional analyses/outputs that need to be generated to characterise the potential DILI issue and assess causality

• Value Added: Open-source software, Hepatotox tool, for production of outputs/analyses in Stage 1 and 2 white papers

Melvin Munsaka, AbbVie

melvin.munsaka@abbvie.com

Terry Walsh, Volunteer

terrencewalsh@yahoo.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global

White Paper

Q4 2023

Finalise Stage 2 of draft White Paper