SS P08 Hepatotoxicity White Paper

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White Paper Title and Lead

Title = Analyses and Displays Associated with Hepatotoxicity – With a Focus on Phase 2-4 Clinical Trials and Integrated Summary Documents
Lead = Terry Walsh, Melvin Munish
FDA Liaison = Eileen Navarro


Creating a first draft for review is in progress.


Targeting May 2014 for a first draft for broad review.
Targeting the end of 2014 for a final white paper.


Several topics were discussed during the PhUSE CSS March 2014 Meeting: See SS P08 18March2014 Standard Scripts Project 08 Meeting for meeting minutes.


Category Identification

Last revised by WendyDobson,10/29/2019