FDA releases draft guidance on evaluating drug behavior in patients with liver impairment

The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairment.

The document emphasizes that reduced liver function can alter drug absorption, metabolism, and clearance, potentially affecting efficacy and safety, and therefore requires specific trial considerations.

The guidance provides recommendations on selecting appropriate patient groups, dosing strategies, and analytical methods to characterize the impact of liver disease on drug exposure and response.

Industry stakeholders are encouraged to incorporate these recommendations into upcoming IND and NDA submissions to ensure regulatory expectations are met.