Trends in the Design and Conduct of Pharmacokinetic Studies in Patients with Impaired Hepatic Function

A pharmacokinetic (PK) study in patients with impaired hepatic function should be conducted in the following situations:

• If hepatic metabolism and/or excretion accounts for substantial portion ( >20 percent of the absorbed drug) of the elimination of a parent drug or active metabolite;
• In the case of a narrow therapeutic range drug, and;
• If metabolism of the drug is unknown.

The design and conduct of these hepatic impairment (HI) studies may have evolved since the latest version of the relevant guidance document from the FDA (2003).

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