Bioequivalence and Bioavailability Forum

Dear MaggieSantos
According to the SmPC the pharmacokinetics of orally administered telmisartan are nonlinear over doses from 20-160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses. The bioequivalence guideline CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states that for drugs with non-linear pharmacokinetics characterised by a more than proportional increase in AUC with increasing dose over the therapeutic dose range, the bioequivalence study should in general be conducted at the highest strength. If bioequivalence has been demonstrated with the 80 mg formulation which is more sensitive to detect a potential difference between products, the in vivo bioequivalence study for the other strength (40 mg) can be waived.
I hope this helps.
Kind regards
Dr_Dan