Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function

Table of contents

This document gives recommendation on situations when pharmacokinetic studies should be performed in subjects with impaired hepatic funtion. It provides guidance on the design of such studies as well as data presentation, analysis, evaluation of results and reflection of those results in the summary of product characteristics.

Keywords: Pharmacokinetics, physiologically based pharmacokinetic modelling (PBPK), hepatic impairment, impaired hepatic function, liver, Child-Pugh classification, population pharmacokinetics, summary of product characteristics

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