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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

Pharma)

terry.walsh@astellas.com

Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@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 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 VenkataramanFDAShayamiEli LillySwarnalatha ReddyIndustryVeronical Pei YangFDAWilliam Palo AbbVie