Metformin FDC [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2015-09-28 18:52 (3455 d 14:28 ago) – Posting: # 15477
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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.

All the best,
Shuanghe

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