Bioequivalence and Bioavailability Forum

Dear Vasu
According to CPMP/QWP/EWP/1401/98 Rev. 1 two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent)after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e. similarity in terms of safety and efficacy. In bioequivalence studies, the plasma concentration time curve is generally used to assess the rate and extent of absorption. Therefore for opthalmic suspension/emulsions the assessment of bioequivalence will not be possible. Please be advised that the "Note for guidance on the clinical requirements for locally applied and locally acting containing known constitues CPMP/EWP/239/95" is applicable. In the summary table at the end of this guideline you will find the answer to your question.
Kind regards
Dan