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Scope

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

Paula Rowley

Nicola Newton, PHUSE Project Assistant

nicky@phuse

paula@phuse

.global

 


Status
colourBlue
titleCurrent Status

 Q12021New team formed and are now aligned on objectives. They are started to draft their White Paper. Due to availability of key members, progress has been slower than planned.

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. 
If you would like to join this project, email: workinggroups@phuse.global



Objectives & Deliverables

TimelinesDraft document for reviewQ32021Users Guide or White PaperQ32021
Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023
Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 Healthcare CorporationPreeti VenkataramanFDASwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVie