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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  

melvin.munsaka@abbvie.com

Terry Walsh

terry.walsh@astellas.com

Paula Rowley (PHUSE Project Assistant)paula@phuse.global 

CURRENT 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.

Objectives & DeliverablesTimelines
Draft document for reviewQ32021
Users Guide or White PaperQ32021
Project MembersOrganisation
Amelia PangSanofi
Charles BeasleyMSN
Darshan Bhatt Industry 
Eileen Navarro AlmarioFDA
Hongli LuMerck
John MarciankAbbVie
Patrick HannonMMS 
Paul HayashiA2 Healthcare Corporation
Preeti VenkataramanFDA
Swarnalatha ReddyIndustry
Veronical Pei YangFDA
William Palo AbbVie
ShayamiEli Lilly
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