Guideline on the pharmacokinetic and clinical evaluation 4 of modified release dosage forms 5 (EMA/CPMP/EWP/280/96 Corr1)

Guideline on the pharmacokinetic and clinical evaluation 4 of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)

The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action.

On August 1, 2010, a revised guidance regarding bioequivalence (BE) assessment for the approval of innovator (bridging studies, variations, line extensions) and generic medicinal products in the EU came into effect (EMA Guideline on the Investigation of Bioequivalence, CPMP/EWP/QWP/1401/98 Rev. 1/Corr**, London, 20 January 2010). This guideline specifies the requirements for BE assessment for i...

Draft Guideline on Clinical Investigation of Medicial Products in the Treatment of Diabetes Mellitus

Discussion in the Efficacy Working Party June 2000 – May 2001 Transmission to CPMP July 2001 Release for consultation July 2001 Deadline for comments January 2002 Discussion in the Efficacy Working Party April 2002 Transmission to CPMP May 2002 Adoption by CPMP May 2002 Date for coming into operation November 2002 Draft Rev. 1 agreed by Efficacy Working Party January 2010 Adoption by CHMP for r...

Guideline on the investigation of drug interactions

Discussion in the Efficacy Working Party (EWP) June/October 1996 February 1997 Transmission to the CPMP March 1997 Transmission to interested parties March 1997 Deadline for comments September 1997 Re-submission to the EWP December 1997 Approval by the CPMP December 1997 Date for coming into operation June 1998 Draft Rev. 1 Agreed by the EWP April 2010 Adoption Rev. 1 by CHMP for release for co...

Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms

Recently, the European Medicines Agency (EMA) published the new draft guideline on the pharmacokinetic and clinical evaluation of modified release (MR) formulations. The draft guideline contains the new requirement of performing multiple dose (MD) bioequivalence studies, in the case when the MR formulation is expected to show 'relevant' drug accumulation at steady state (SS). This new requireme...