Hepatotoxicity in Drug Development: A Regulatory Perspective

Nov 16 2024
Convention Center: Room 25 B
7:00 AM - 7:45 AM
Ticketed Event

World Class Speakers

Paul Hayashi, MD, MPH, FAASLD
Discussion Leader

Paul Hayashi, MD, MPH, FAASLD

FDA
Naga P Chalasani, MD, FAASLD
Discussion Leader

Naga P Chalasani, MD, FAASLD

Indiana University Medical Center

Description

The speakers address assessment of hepatotoxicity in clinical trials from the prespective of the US Food and Drug Administration (FDA). As clinical studies and trials are generally powered for efficacy but not safety, monitoring for hepatic safety and adjudicating hepatic safety events are a mixture of art and science. Two experts with extensive knowledge regarding clinical drug hepatotoxicity discuss monitoring and adjudication approaches, and how the FDA evaluates for liver safety signals in new drug marketing applications.

Journey Maps

Objectives

  • Explain how the FDA assesses liver safety and hepatotoxicity data during new drug applications, including those with abnormal baseline liver analytes.
  • Describe the data included in the evaluation of drug-induced serious hepatotoxicity (eDISH) plots, and eDISH strengths and limitations.
  • Discuss how liver safety is best evaluated in clinical trials by academic and industry clinical trialists.