Pharmacokinetic studies in man - Scientific guideline

This document aims to provide guidance on preclinical and clinical pharmacokinetic investigations of a new medicinal product, irrespective of the nature, mode of action or route of administration, in healthy volunteers and patients.

Keywords: Pharmacokinetics, absorption, distribution, metabolism, elimination, ADME, bioavailability, interactions, administration, healthy volunteers, patients, sampling, analysis, data processing, statistics

Current effective version

Pharmacokinetic studies in man

Adopted Reference Number: 3CC3a Legal effective date: 01/10/2015