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 PharmCat – Russia, 2019-11-13 21:25 – Posting: # 20801
Views: 1,339

» i.e. 2 tablets. All of these drugs are reference drugs according to the GRLS system.
»
» What is your opinion which option to choose?

Hello!

Strictly for bioequivalence you should chose drug from register that have label "Reference drug". If no such drug - you should make
efficacy trial.

I heard there was a case when drug was registered in EU and BE in Russia was performed with separate reference drugs - but now this case is not approvable, but some companies try to do this.

If say strict - both cases is wrong.

Complete thread:

Reference drugs for triple combination test drug in Russia Beholder 2019-11-13 12:47 [Design Issues]
- Reference drugs for triple combination test drug in RussiaPharmCat 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