BE for the EMA [Regulatives / Guidelines]
❝ 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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