Metformin FDC [Regulatives / Guidelines]
Hi Margarida,
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.
❝ 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
All the best,
Shuanghe
Complete thread:
- Metformin FDC MaggieSantos 2015-09-25 19:39 [Regulatives / Guidelines]
- Metformin FDCShuanghe 2015-09-28 16:52