Bioequivalence and Bioavailability Forum • Reference drugs for triple combination test drug in Russia

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

posted by Beholder – Russia, 2019-11-13 13:47 (1798 d 14:49 ago) – Posting: # 20798
Views: 7,631

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:

Reference drugs for triple combination test drug in RussiaBeholder 2019-11-13 12:47 [Design Issues]
- Reference drugs for triple combination test drug in Russia PharmCat 2019-11-13 21:25
  - Reference drugs for triple combination test drug in Russia Yura 2019-11-14 09:24
    - Reference drugs for triple combination test drug in Russia Beholder 2019-11-14 10:55
  - Reference drugs for triple combination test drug in Russia Beholder 2019-11-14 10:51
    - Reference drugs for triple combination test drug in Russia Mikalai 2019-11-15 13:36
      - OT: Speak with the regulator Helmut 2019-11-15 13:45
    - Reference drugs for triple combination test drug in Russia PharmCat 2019-11-15 20:07
      - Reference drugs for triple combination test drug in Russia mittyri 2019-11-15 23:29
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-16 17:22
      - Reference drugs for triple combination test drug in Russia Beholder 2019-11-18 10:13
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-18 22:47
        
        WHO FDC Scenario 2 mittyri 2019-11-19 09:25
        
        WHO FDC Scenario 2 PharmCat 2019-11-19 23:42
        
        EEU FDC Scenario 5.3.2 mittyri 2019-11-20 11:32
        
        EEU FDC Scenario 5.3.2 PharmCat 2019-11-20 15:39
        
        EMA example mittyri 2019-11-21 12:38
        
        Reference drugs for triple combination test drug in Russia Beholder 2019-11-19 14:39
        
        Reference drugs for triple combination test drug in Russia Yura 2019-11-19 21:51
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-21 14:02