Reference drugs for triple combination test drug in Russia [Design Issues]

posted by Beholder  – Russia, 2019-11-13 12:47  – Posting: # 20798
Views: 1,860

Hi to all!

Question mostly for Russian members of the forum but anybody who has smth to add is really welcomed.

There is such a situation: a triple combination (3 molecules in one tablet) will be studied in BE study. As reference drugs we can choose two options:

1. a combination of three separate single drugs (i.e. 3 separate tablets) i.e. 3 tablets
2. a combination of one FDC (2 molecules in one tablet) and a single drug (1 molecule in one tablet), i.e. 2 tablets. All of these drugs are reference drugs according to the GRLS system.

What is your opinion which option to choose?

Thanks in advance for your answers.

Best regards
Beholder

Complete thread:

Activity
 Admin contact
20,103 posts in 4,243 threads, 1,382 registered users;
online 13 (0 registered, 13 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 07:51 CET

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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