The staff of CPMI has maintained a population of patients with Hepatic Impairment for a number of years. The size of this population varies but averages between 30 -50 patients at any given time. Most of these patients are cirrhotic patients as a result of alcohol abuse and are classified as either Child-Pugh A or Child-Pugh B. Our ability to recruit Child-Pugh C (severely impaired) patients is limited by the fact that these subjects are usually quite sick and not able to participate in studies. Nevertheless our population of patients has allowed us to complete a number of FDA mandated studies every year according to the guidance that they have published.
Guidance for Industry
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling