Bioequivalence and Bioavailability Forum

Hi Joy!

❝ How would you conduct/assess BE of 2 drug products of the same active ingredient but of different dosage formats and strengths i.e. immediate-release, 130 mg per tablet versus sustained-release, 200 mg per tablet?

It’s not possible to show bioequivalence between an immediate release and a modified release form – although the extent of BA may be the same, just by definition the rate of BA should be different.
Another point in the definition of BE requires administration of the same molar dose. Since the least common multiple of 200 and 130 ist 2600, it would mean comparison of 20 IR tablets v.s. 13 SR tablets.
I’m afraid, in this case the cards are stacked against you…

At least if your drug shows linear pharmacokinetics within 130 mg and 200 mg you may perfom a comparative bioavailability study and normalize dose-dependent PK parameters of the 200 mg formulation to 130 mg; but remember, this is not BE.