Metformin FDC [Regulatives / Guidelines]

posted by MaggieSantos – Portugal, 2015-09-25 21:39 (3924 d 10:46 ago) – Posting: # 15472
Views: 4,658

Dear Sirs:

I have to evaluate BE for sitagliptin plus metformin FDC formulations (50/1000 and 50/850) as well as for vildagliptin plus metformin FDC (50/850 and 50/1000).

Concerning the guideline on investigation of bioequivalence could I waive BE for the lower strenght, assuming the a) and b) requirements?

Kind Regards

Margarida Barreto

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
111 visitors (0 registered, 111 guests [including 18 identified bots]).
Forum time: 08:26 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5