BE for the EMA [Regulatives / Guidelines]

posted by Ohlbe – France, 2023-05-16 10:51 (1140 d 13:57 ago) – Posting: # 23559
Views: 4,237

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
23,656 posts in 4,994 threads, 1,570 registered users;
202 visitors (0 registered, 202 guests [including 26 identified bots]).
Forum time: 00:49 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas.    Paul Feyerabend

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