The guideline defining when bioequivalence studies are necessary and how they should be designed, conducted and evaluated has been released for public consultation (Doc. Ref. CPMP/EWP/QWP/1401/98 Rev. 1). The deadline for comments is 31 January 2009. Comments should be provided to EWPSecretariat@emea.europa.eu using this template. The guideline focuses primarily on bioequivalence for immediate release dosage forms with systemic action.
Bioequivalence studies are mainly needed for generic applications, but may also be applicable to hybrid application, extensions and variations applications, and to different formulations used during the development of a new medicinal product containing a new chemical entity. The latest draft describes how studies need to be designed and conducted and defines requirements for reference and test product. Furthermore it provides information which characteristics should be investigated and how the study has to be evaluated and presented.
Five appendices are annexed to the document:
On behalf of the European Compliance Academy (ECA)