Bioequivalence and Bioavailability Forum

Dear PJS
Honestly, I do not understand your question. The originator demonstrated linearity after i.v. and oral administration (irrespectively of formulation type tablet or solution). I guess you develop an oral solution formulation whereas the originator is a solid oral formulation. In this case your formulation is no generic. In order to make reference to the originator´s dossier in a mixed application you need to show bioequivalence of your oral solution formulation against the solid oral formulation. Since the drug is a BCS class III substance it will become hard to achieve equivalence in terms of AUC and Cmax using the same strength. Good luck! I guess you will need a clinical study in order to demonstrate safety and efficacy.
I hope this helps.
Kind regards
Dr_Dan