M-CERSI Workshop: Assessing Changes in Pharmacokinetics of Drugs in Liver Disease

Thursday, October 8, 2020
10:00 a.m.-4:00 p.m.
Ann Anonsen

Collaborative workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)

Assessing Changes in Pharmacokinetics of Drugs in Liver Disease

This workshop aims to bring together stakeholders from FDA, academia, and industry in a virtual setting to discuss advances to improve assessing the impact of hepatic function on the pharmacokinetics of a drug.


This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.





Thursday, October 8, 2020, 10:00am-4:00pm

Virtual Meeting


'Drug development for a target population includes patients with various comorbidities, including liver disease. Patients with liver disease can have a decreased capacity to eliminate drugs via the liver and may require dosage adjustments. Dosage adjustment is typically based on bridging pharmacokinetic parameters between a population with impaired hepatic function to a population with normal hepatic function. This requires reliable biomarkers that identify and classify the underlying impairment in hepatic function by reflecting the trajectory of changes in biotransformation capacity due to liver disease. While current FDA guidance has been the standard for evaluating the impact of impaired hepatic function on the pharmacokinetics of new drugs, challenges in implementation include difficulties in enrolling patients, delays in hepatic impairment studies until late in the drug development, and the fact that current markers of hepatic function are more relevant for patients with cirrhosis.

Key Topics of Discussion

  • Relevant biomarkers and their predictive ability to identify changes in biotransformation and transport capacity of the liver

  • Classification of degree of impairment in biotransformation and transport capacity of the diseased liver

  • Potential differences in pharmacokinetics in different underlying liver diseases

  • The role of PBPK in characterizing the PK of drugs in hepatic impairment

Audience: Public 

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