Pharmacokinetic and clinical evaluation of modified-release dosage forms

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Current effective version

Adopted guideline

Reference numberEMA/CPMP/EWP/280/96 Corr. 1
Published27/11/2014
Effective from01/06/2015
KeywordsModified release, prolonged release, delayed release, transdermal drug delivery systems (TDDS), bioequivalence, pharmacokinetics, biowaiver, in vitro dissolution, generics, oral, intramuscular, subcutaneous
DescriptionThis 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.


Document history

First version

Current version

Adopted guideline


Draft guideline


Concept paper

In operation: 01/06/2015–present


Published: 15/03/2013


Published: 08/06/2010

Superseded documentAdopted guidelineIn operation: 01/06/2003–31/05/2015
Superseded documentAdopted guidelineIn operation: 01/01/2000–31/05/2015


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