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, 2019-11-15 21:07 (1788 d 16:03 ago) – Posting: # 20809
Views: 5,771

❝ Hi PharmCat!

❝

❝ Why second is wrong?

If you look at federal law, you can find:

generic drug - a drug that has the same qualitative composition and quantitative composition of active substances in the same dosage form as the reference drug, and whose bioequivalence or therapeutic equivalence is confirmed by the reference drug with relevant studies.

That why I said "strictly", triple FDC can be compared with similar registered triple FDC.

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

You mention clinical trial with HIV drug and 280 subjects in 2 sites - may be this is exception.

In general case you can do BE vs equal FDS or therapeutic equivalence.

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 RussiaPharmCat 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