BE for the EMA [Regulatives / Guidelines]

posted by Ohlbe – France, 2023-05-16 10:51 (782 d 05:31 ago) – Posting: # 23559
Views: 2,740

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.
—
Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,677 registered users;
43 visitors (0 registered, 43 guests [including 8 identified bots]).
Forum time: 16:23 CEST (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5