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Assessing DILI Risk in the Life-cycle of Drugs & Biologics: A Challenge for Regulatory Science


Monday, October 23, 10-10:30 am


  • Mark I. Avigan, MD


  • Robert J. Fontana, MD, FAASLD

Continuing Education Information

  • CME – 0.5 AMA PRA Category 1 Credits™ 

Learning Objectives

Upon completion of this activity, participants will be able to:

  • Review information about hepatotoxicity of a drug from different phases of the life-cycle.
  • Recognize diverse clinical signatures and mechanisms that underly hepatotoxicity.
  • Become familiar with methods used for the assesment of liver injury, severity and drug-related casualty.

Session Description/Needs Statement

Drug-induced liver injury (DILI) remains the leading cause of acute liver failure in the U.S. This session will review methods that are used by clinical and regulatory scientists to gather information about the hepatotoxicity of a drug or biological agent, during each phase of its life cycle.  The session will highlight the diverse clinical signatures and mechanisms that underlie DILI and discuss critical challenges when analyzing drug-related risk for serious liver toxicity.