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RegisterBE for the EMA [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2023-05-15 15:40 (483 d 17:53 ago) – Posting: # 23556
Views: 1,942
Hi Raman,
Yes (see the applicable guideline about ‘pharmaceutical alternatives’).
What do you mean by ‘AUC (total)’? You need to demonstrate BE for Cmax and AUC0-tlast (alternatively AUC0-72).
❝ For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength.
Yes (see the applicable guideline about ‘pharmaceutical alternatives’).
❝ If yes, whether both Cmax and AUC (total) to be included in the criteria?
What do you mean by ‘AUC (total)’? You need to demonstrate BE for Cmax and AUC0-tlast (alternatively AUC0-72).
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Design for the EMA ryraman2661 2023-05-15 13:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE for the EMAHelmut 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 EMAHelmut 2023-05-15 13:40
Ing. Helmut Schütz