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RegisterDesign [Regulatives / Guidelines]
Dear Members,
I have one point to be discussed in the forum.
For Bioequivalence studies for EU submission , can we compare capsules VS tablets of same drug,and same strength.
If yes, whether both Cmax and AUC (total) to be included in the criteria? or we can compare only AUC (total).
What are the others points to be taken care.
Members can give their opinion .
Thanks
Raman
Chennai
I have one point to be discussed in the forum.
For Bioequivalence studies for EU submission , can we compare capsules VS tablets of same drug,and same strength.
If yes, whether both Cmax and AUC (total) to be included in the criteria? or we can compare only AUC (total).
What are the others points to be taken care.
Members can give their opinion .
Thanks
Raman
Chennai
Complete thread:
- Designryraman2661 2023-05-15 13:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE for the EMA Helmut 2023-05-15 13:40
- BE for the EMA ryraman2661 2023-05-16 08:04
- BE for the EMA Ohlbe 2023-05-16 08:51
- BE for the EMA Helmut 2023-05-15 13:40
Ing. Helmut Schütz