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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


Status
colourBlue
titleCurrent Status
Q1 Q2 2024

  • Completed incorporating the second round of comments from FDA reviewers.  
  • Will be routing the Stage 1 White Paper for the PHUSE executive review and thereafter post for public review. FDA comments incorporated into the WP



Objectives & Deliverables

Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023