Pharmacokinetic studies in man - Scientific guideline
HumanScientific guidelines
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
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