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 open
First published 15/03/2013
Last updated 15/03/2013
Consultation start date 15/03/2013
Consultation end date 15/09/2013
Email address for submissions pkwpsecretariat@ema.europa.eu

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.