Metformin FDC [Regulatives / Guidelines]

posted by MaggieSantos – Portugal, 2015-09-25 21:39 (3430 d 08:44 ago) – Posting: # 15472
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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

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