Pharmacokinetic studies are used to identify special subgroups of patients in whom an
alternative dosing regimen may be indicated for efficacy and/or safety reasons. Since liver is an
important organ with respect to drug disposition, patients with hepatic impairment constitute
an important subgroup of such special populations.
Hepatic function decreases with age, but due to the high capacity of the liver this is considered
not to change the pharmacokinetics to a clinically relevant extent. Liver disease, however, is
known to be a common cause of altered pharmacokinetics of drugs