Bioequivalence and Bioavailability Forum

Hi Margarida,

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

If I remember it correctly, metformin pk is not linear. It's increase less than proportional so probably BE should be demonstrate with lower strength (or lowest and highest). I vaguely recall that there is an EPAR also mentioned this. I don't have time to check it but you should search EPAR database for it.