Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline

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.

Current effective version

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

AdoptedReference Number: EMA/CHMP/EWP/280/96 Rev1Summary:

The primary purpose of this guideline is to define 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 and to set out general principles for designing, conducting and evaluating such studies.

Document history

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

AdoptedReference Number: EMA/CHMP/EWP/280/96 Rev1Summary:

The primary purpose of this guideline is to define 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 and to set out general principles for designing, conducting and evaluating such studies.

Overview of comments received on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms

Reference Number: EMA/CHMP/267430/2019

Outcome of public consultation on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms

Reference Number: EMA/CHMP/536342/2019

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

Consultation dates: 15/03/2013 to 15/09/2013Draft: consultation closedReference Number: EMA/CHMP/EWP/280/96 Rev1Summary:

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.

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)

Consultation dates: 20/05/2010 to 31/08/2010Draft: consultation closedReference Number: EMA/CHMP/1303/2010

Superseded documents

Points to consider on the clinical requirements of modified release products submitted as a line extension of an existing marketing authorisation - Superseded

AdoptedLegal effective date: 01/06/2003Reference Number: CPMP/EWP/1875/03/Final

Note for guidance on modified release oral and transdermal dosage forms: Section II (pharmacokinetic and clinical evaluation) - Superseded

AdoptedLegal effective date: 01/01/2000Reference Number: CPMP/EWP/280/96/ Corr