Bioequivalence and Bioavailability Forum

Dear All,

I would like to have your opinion on the chance to aply a biowaiver to the lower dosages of Telmisartan alone or FDC with telmisartan. (from 80 mg to 40 mg)

Since there is no pharmacokinetic linear relationship between doses and plasma concentrations, I am not quite sure if the bioequivalence study with the 80 mg telmisartan dosages (alone or as FDC) is enough to biowave the 40 mg dosages (assuming all other permisses are fulfilled).


Best Regards

MaggieSantos