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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

Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse

nicky@phuse.global

 

Objectives & Deliverables

Timelines 

Finalise stage 1 of draft White Paper for Public Review

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

2024

  • FDA comments incorporated into the WP



Objectives & Deliverables

Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023
William Palo AbbVie