Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms

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Download document Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
Reference number EMA/CHMP/EWP/280/96 Rev.1
Status draft: consultation closed
First published 2013-03-15
Last updated 2013-03-15

Summary

The primary purpose of this guideline is to define the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified-release and transdermal dosage forms in man and to set out general principles for designing, conducting and evaluating such studies.