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RegisterMetformin FDC [Regulatives / Guidelines]
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
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
Complete thread:
- Metformin FDCMaggieSantos 2015-09-25 19:39 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Metformin FDC Shuanghe 2015-09-28 16:52
Ing. Helmut Schütz