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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 2023 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. 
Working on a White Paper



Objectives & Deliverables

Timelines 

Finalise

stage

Stage 1 of draft White Paper

for Public Review

Q2
Q4 2023