New FDC - BE reference products [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2015-11-03 10:27 (3385 d 18:59 ago) – Posting: # 15609
Views: 4,450

Dear all
If you develop a new fixed dose combination with known APIs and you have shown BE of the combination against the US mono reference products do you need to repeat the study with European reference products in case you aim not for substitution indication (according to §10(b)) but go for a mixed application according to §8.3? What is your experience?
Looking forward to your replies.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,665 registered users;
137 visitors (0 registered, 137 guests [including 7 identified bots]).
Forum time: 05:26 CET (Europe/Vienna)

There are sadistic scientists who hurry to hunt down errors
instead of establishing the truth.    Marie Curie

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