Bioequivalence and Bioavailability Forum • BE for the EMA

BE for the EMA [Regulatives / Guidelines]

posted by Ohlbe – France, 2023-05-16 10:51 (511 d 04:16 ago) – Posting: # 23559
Views: 1,943

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

Design for the EMA ryraman2661 2023-05-15 13:03 [Regulatives / Guidelines]
- BE for the EMA Helmut 2023-05-15 13:40
  - BE for the EMA ryraman2661 2023-05-16 08:04
  - BE for the EMAOhlbe 2023-05-16 08:51