Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms

The EUFEPS BABP Network Open Discussion Forum Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms was held June 17-18, 2013, Bonn, Germany.

Scope & Aim
Revised European guideline on modified release dosage forms has been published by the European Medicines Agency. Two years ago, in February 2011, the EUFEPS Network on Bioavailability and Biopharmaceutics set up a workshop on the topic in Barcelona to provide input for revision of the existing CPMP Note for Guidance on modified release, and it was successfully done. The aim of this event, the 2013 BABP Open Discussion Forum, is to discuss relevant matters and issues as to the draft revised guideline, now released by the EMA and CHMP, on March 15, 2013 (EMA/CPMP/EWP/280/96 Corr1) for a 6 months consultation period. Keywords of it include: Modified release, prolonged release, delayed release, transdermal drug delivery systems (TDDS), bioequivalence, pharmacokinetics, biowaiver, in vitro
dissolution, and generics.

The guideline addresses studies needed to investigate modified release drug delivery systems in man and is communicating general principles for designing, conducting and evaluating the studies. There are three sections of it:

• Modified release forms of new chemical entities
• Modified release formulation of a drug that is authorised as an immediate release formulation
• Modified release forms referring to a marketed modified release form

Outcome
The outcome of the meeting was sent as feedback to EMA.