Bioequivalence and Bioavailability Forum

MaggieSantos ☆ Portugal, 2015-09-25 21:39 (3931 d 10:06 ago) Posting: # 15472 Views: 4,695	Metformin FDC [Regulatives / Guidelines] Post reply
	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

Shuanghe
★★

Spain,
2015-09-28 18:52
(3928 d 12:52 ago)

@ MaggieSantos
Posting: # 15477
Views: 3,497

Metformin FDC

Post reply

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.

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All the best,
Shuanghe

Metformin FDC [Regulatives / Guidelines]

Metformin FDC