Design for the EMA [Regulatives / Guidelines]

posted by ryraman2661 – India, 2023-05-15 15:03 (425 d 02:43 ago) – Posting: # 23554
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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.



Edit: Subject line changed; see also this post #2. [Helmut]

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