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Project Scope 

This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.



Project LeadsEmail

Melvin Munsaka, AbbVie

melvin.munsaka@abbvie.com

Terry Walsh, Astellas

terry.walsh@astellas.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


Complete background work for Stage 2
  • Get Stage 1 White Paper out for public review before end of October

    • Status
    colourBlue
    titleCurrent Status
    Q4 2023

    Q1 2024

    • FDA comments incorporated into the WP



    Objectives & Deliverables

    		Timelines 

    Finalise Stage 1 of draft White Paper

    		Q4 2023