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Project Scope
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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 Leads

Email

Melvin Munsaka

(

, AbbVie

) (Astellas)terry.walsh@astellasKatie Warren (

Nicola Newton, PHUSE Project

Assistant)

Coordinator

katie@phuse 

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Click above for the latest project status.

Objectives & Deliverables

Timelines 

Finalise stage 1 of draft for Public ReviewWilliam Palo AbbVie

Q2 2023

Status
colourBlue
titleCurrent Status
Q1 2023

  • Working on a White Paper
Project MembersOrganisationAmelia PangSanofiCharles BeasleyMSNDarshan Bhatt Industry Eileen Navarro AlmarioFDAHongli LuMerckJohn Landry Eli LillyJohn MarciankAbbViePatrick HannonMMS Paul HayashiA2 Healthcare CorporationPreeti VenkataramanFDAShayamiEli LillySwarnalatha ReddyIndustryVeronical Pei YangFDA

Q4 2023

Finalise Stage 2 of draft White Paper