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 Yura – Belarus, 2019-11-19 22:51 (2414 d 06:09 ago) – Posting: # 20830
Views: 11,651

Hi Beholder,
There is no reason for the regulator not to want to check section 4.5 of the Guideline on clinical development of fixed combination medicinal products :|>
Kind regards,
Yura

Edit: Guideline linked. Also changed the name in signature to the usual one[Mittyri]

Complete thread:

Reference drugs for triple combination test drug in Russia Beholder 2019-11-13 12:47
- 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 RussiaYura 2019-11-19 21:51
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-21 14:02