Primary source: Download the Draft Guidance Document
The FDA has proposed recommendations that pharmacokinetic studies should be conducted for drugs if hepatic metabolism or excretion accounts for more than 30% of the elimination of the drug.
This guidance affects how pharmaceutical companies design studies and label drugs, ensuring that dosing is appropriate for patients with liver impairment, thereby enhancing patient safety and compliance.
Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.
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Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.
The FDA has released draft guidance that outlines the study design and data analysis methods for evaluating pharmacokinetics in patients with impaired hepatic function. The guidance is not for implementation yet, and it encourages sponsors to consider the influence of hepatic impairment on dosing and labeling of drugs.
What changed: The FDA has proposed recommendations that pharmacokinetic studies should be conducted for drugs if hepatic metabolism or excretion accounts for more than 30% of the elimination of the drug.
Why it matters: This guidance affects how pharmaceutical companies design studies and label drugs, ensuring that dosing is appropriate for patients with liver impairment, thereby enhancing patient safety and compliance.
Practical implication: Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.
Published from the regulator source ingestion pipeline after PV impact triage.
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Review and update labeling processes in accordance with the newly published safety-related changes for affected products.
