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 mittyri – Russia, 2019-11-16 00:29 (1896 d 11:13 ago) – Posting: # 20811
Views: 8,317

Hi PharmCat!

❝ Anyway can be some exceptions when this rule not work. May be it can be orphan drugs or some individual cases or regulatory abuse.

"The exception that proves the rule"
Just what I have found in GRLS and that drugs were approved within a BE study against 2 Reference drugs
Amlodipine + Indapamide + Perindopril
Losartan + Amlodipine + Rosuvastatin
Indapamide + Rosuvastatin + Perindopril
(could be more, lazy to search)

I would not name it 'orphan' or 'individual' :-)

Generic companies did develop almost all attractive double combinations for cardiovasulcar diseases and were trying to expand to triple combinations.

—
Kind regards,
Mittyri

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 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 Russiamittyri 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