BE for the EMA [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2023-05-15 15:40 (340 d 20:19 ago) – Posting: # 23556
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Hi Raman,

❝ 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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