Guideline on Investigation of Bioequivalence released for Public Consultation

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 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:

  • I: Dissolution testing: the several purposes of dissolution tests in Bioequivalence studies are described
  • II: Bioequivalence study requirements for different dosage forms: depending on the type of formulation, the different requirements regarding support of data from bioequivalence are described in this appendix.
  • III: BCS-based Biowaiver: showing how the BCS (Biopharmaceutics Classification System)-based biowaiver approach can reduce in vivo bioequivalence studies
  • IV: Decision tree on measurement of parent compound or metabolite
  • V: Decision tree on selection of dose and strength in bioequivalence studies

Compiled by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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