Bioequivalence and Bioavailability Forum

Dear Tali!

❝ is there any expirience in performing bioequivalence study of tablets

❝ versus solutions or sirups?

Yes and no. Bioequivalence implies formulations which are pharmaceutical equivalents (IR tablet vs. IR tablet) or pharmaceutical alternatives (IR tablet vs. IR capsule). If there is no suitable reference marketed, you may want to assess the Relative Bioavailability: tablet vs. solution, or if no solution can be obtained, a suspension. For a definition of terms see the European Note for Guidance (Sections 2.3 and 2.4).

❝ Besides of the technical issue is there a regulatory reference to this

❝ question.

This depends on the rationale of the study. In product development of MR it's not uncommon to run in vivo studies with a solution as a reference in order to obtain the in vivo input function. If you want to go for an abbreviated market authorisation (=generic product), a solution will not do the job!