BE for the EMA [Regulatives / Guidelines]

posted by Ohlbe – France, 2023-05-16 10:51 (343 d 18:31 ago) – Posting: # 23559
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Dear 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’).


... but only for immediate release products. Not for modified release. See section 1.2 of the guideline and article 10(2)(b) of Directive 2001/83/EC.

Regards
Ohlbe

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