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Assessing Changes in Pharmacokinetics of Drugs in Liver Disease is an online workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA.

Key Topics of disussion include:

  • 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 to aid drug development and dosing recommendations 

  • Research on potential differences in PK in different underlying liver diseases

  • Research on the potential to utilize modelling and simulation approaches to obtain dosing recommendations in patients with impaired hepatic function. 


More information about this workshop, is available HERE.

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