Bioequivalence and Bioavailability Forum

Dear Sofiya
Of course you can investigate comparative bioavailability of an orally disintegrating strip against a film coated tablet since both formulations are immediate release formulations. An orally disintegrating strip is formulated to quickly disintegrate in the mouth. Placement in the mouth and time of contact may be critical in cases where the active substance also is dissolved in the mouth and can be absorbed directly via the buccal mucosa. Depending on the formulation, swallowing of the e.g. coated substance and subsequent absorption from the gastrointestinal tract also will occur. If it can be demonstrated that the active substance is not absorbed in the oral cavity, but rather must be swallowed and absorbed through the gastrointestinal tract, then the product might be considered for a BCS based biowaiver. If this cannot be demonstrated, bioequivalence must be evaluated in human studies.
For further Information see CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** Appendix 2.
I hope this helps.
Kind regards
Dr_Dan