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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

)

paula@phuse

nicky@phuse.global

 


Status
colourBlue
titleCurrent Status

Q3/42021

The group have started to draft their White Paper and is currently in progress.

Wide scope of examples have now been gathered.

Q1 2024

  • FDA comments incorporated into the WP



Objectives & Deliverables

TimelinesDraft document for reviewQ32021Users Guide or White PaperQ32021Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 Healthcare CorporationPreeti VenkataramanFDASwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVieShayamiEli Lilly
Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023