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

posted by Beholder  – Russia, 2019-11-13 13:47 (2008 d 03:40 ago) – Posting: # 20798
Views: 10,341

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:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
89 visitors (0 registered, 89 guests [including 65 identified bots]).
Forum time: 18:28 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other.    Thomas Berger

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