Generic FDC drug vs two monoproduct drug or vs "originator" FDC drug? [Design Issues]

posted by Beholder  – Russia, 2018-09-04 09:12 (817 d 02:03 ago) – Posting: # 19234
Views: 2,938

Hello to everybody!

There is generic FDC drug named AB which is intended to be studied in BE study. There are two options to choose reference drug (s) for that study:
1. two separate monoproducts - named drug A and drug B. Both drugs considered as reference drugs
2. "original" FDC drug named AB which is also considered as reference drug.
Which drug (s) to choose as reference drug (s)? What would be your opinion?
THX in advance.

Best regards

Complete thread:

 Admin contact
21,217 posts in 4,427 threads, 1,481 registered users;
online 15 (0 registered, 15 guests [including 13 identified bots]).
Forum time: Sunday 11:15 UTC (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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