Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline
Table of contents
This document defines the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified release formulations following oral, intramuscular and subcutaneous administration and transdermal dosage forms in man. It aims to set out general principles for designing, conducting and evaluating such studies. The overview of comments would be soon available on this page.
Keywords: Modified release, prolonged release, delayed release, transdermal drug delivery systems (TDDS), bioequivalence, pharmacokinetics, biowaiver, in vitro dissolution, generics, oral, intramuscular, subcutaneous.
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Guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms (PDF/1.41 MB)
Adopted
First published: 27/11/2014
Last updated: 27/11/2014
EMA/CHMP/EWP/280/96 Rev1 -
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Overview of comments received on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms (PDF/1.85 MB)
First published: 29/10/2019
EMA/CHMP/267430/2019 -
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Outcome of public consultation on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms (PDF/253.33 KB)
First published: 29/10/2019
EMA/CHMP/536342/2019 -
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Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms (PDF/676.89 KB)
Draft: consultation closed
First published: 15/03/2013
Last updated: 15/03/2013
Consultation dates: 15/03/2013 to 15/09/2013
EMA/CHMP/EWP/280/96 Rev1 -
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Concept paper on the need for revision of the note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation) (PDF/78.01 KB)
Draft: consultation closed
First published: 08/06/2010
Last updated: 08/06/2010
Consultation dates: 20/05/2010 to 31/08/2010
EMA/CHMP/1303/2010
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Points to consider on the clinical requirements of modified release products submitted as a line extension of an existing marketing authorisation - Superseded (PDF/148.53 KB)
Adopted
First published: 17/12/2003
Last updated: 17/12/2003
Legal effective date: 01/06/2003
CPMP/EWP/1875/03/Final -
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Note for guidance on modified release oral and transdermal dosage forms: Section II (pharmacokinetic and clinical evaluation) - Superseded (PDF/122.31 KB)
Adopted
First published: 28/07/1999
Last updated: 28/07/1999
Legal effective date: 01/01/2000
CPMP/EWP/280/96/ Corr