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Analyses & Displays for Hepatotoxicity

Analyses & Displays for Hepatotoxicity

yesterday at 4:27 pm

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

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

CURRENT STATUS (Updated Quarterly) 

  • Stage 2 white paper draft moving along well​
  • Stage 1 white paper Hepatotox R package created on Github​
  • Validation resource for Hepatotox R package identified
  • Finalise Stage 2 white paper.​
  • Finalise R Package Hepatotox tool forStage1 white paper.​
  • Embark on Hepatotox R package for Stage 2 white paper.

Objectives & Deliverables

Timelines 
White PaperQ4 2023

Finalise Stage 2 of draft White Paper