Log in
Register|
MaggieSantos ☆ Portugal, 2014-06-16 18:54 (4391 d 19:53 ago) Posting: # 13071 Views: 3,811 |
|
|
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 |
|
Dr_Dan ★★ Germany, 2014-06-18 10:47 (4390 d 03:59 ago) @ MaggieSantos Posting: # 13080 Views: 2,925 |
|
|
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 — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz