BE for the EMA [Regulatives / Guidelines]

posted by Ohlbe – France, 2023-05-16 10:51 (136 d 18:13 ago) – Posting: # 23559
Views: 740

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.


Complete thread:

UA Flag
 Admin contact
22,763 posts in 4,775 threads, 1,627 registered users;
21 visitors (0 registered, 21 guests [including 8 identified bots]).
Forum time: 05:04 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us.    Quintilian

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz