Assessing and Managing DILI Risk in Trials: A Consultant’s Perspective

Authors: Watkins PB
Conference: DILI
Keywords: drug induced liver injury (DILI), hepatotoxic potential, hepatotoxicity, liver dysfunction, liver injury
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

Thoughts on the New Guidance

1). Define “signatures of DILI”

2). Encourage mechanistic research

3). Encourage novel use of DILI biomarkers and eDISH

US FDA & AASLD DILI Conference at the University of Maryland University College May 7-8, 2019

By Paul B Watkins