Analyses & Displays for Hepatotoxicity

Created by Wendy Dobson, last modified on Dec 14, 2020

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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	melvin.munsaka@abbvie.com
Terry Walsh	terry.walsh@astellas.com
Wendy Dobson (PHUSE Project Manager)	wendy@phuse.global

CURRENT STATUS Q42020
New team formed and kick off meeting taken place. Presented at the recent CSS

Deliverables	Timelines
Users Guide or White Paper	Q32021

Project Members	Company
Amelia Pang	Sanofi
Eileen Navarro Almario	FDA
John Marciano	AbbVie
Patrick Hannon	MMS
Preeti Venkataraman	FDA
Swarnalatha Reddy	Covance
Veronical Pei Yang	FDA
William Palo	AbbVie

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