Pharmacokinetic studies in man

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Current effective version

Adopted guideline

Reference number3CC3A
Published01/02/1987
Effective from01/10/1988
KeywordsPharmacokinetics, absorption, distribution, metabolism, elimination, ADME, bioavailability, interactions, administration, healthy volunteers, patients, sampling, analysis, data processing, statistics
DescriptionThis 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.


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