Bioequivalence and Bioavailability Forum

Dear aanrin
What would be the reason for conducting a BE study of naproxen 220mg against the competitor strength of 200mg? Both formulation should not be bioequivalent, right? A medicinal product is therapeutically equivalent with another product if it contains the same active substance or therapeutic moiety and, clinically, shows the same efficacy and safety as that product, whose efficacy and safety has been established. In practice, demonstration of bioequivalence is generally the most appropriate method of substantiating therapeutic equivalence. Your product is not therapeutically equivalent and therefore you will need data for safety and efficacy of your own formulation (strength). So you are obliged to conduct at least one phase III study.
I hope this helps.
Kind regards
Dr_Dan