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

posted by Beholder  – Russia, 2019-11-13 13:47 (2059 d 18:06 ago) – Posting: # 20798
Views: 10,710

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

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