Reference drugs for triple combination test drug in Russia [Design Issues]
Hi PharmCat!
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.
❝ Anyway can be some exceptions when this rule not work. May be it can be orphan drugs or some individual cases or regulatory abuse.
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
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
- EEU FDC Scenario 5.3.2 PharmCat 2019-11-20 15:39
- EEU FDC Scenario 5.3.2 mittyri 2019-11-20 11:32
- WHO FDC Scenario 2 PharmCat 2019-11-19 23:42
- 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
- Reference drugs for triple combination test drug in Russia Yura 2019-11-19 21:51
- WHO FDC Scenario 2 mittyri 2019-11-19 09:25
- Reference drugs for triple combination test drug in Russia PharmCat 2019-11-18 22:47
- Reference drugs for triple combination test drug in Russiamittyri 2019-11-15 23:29
- Reference drugs for triple combination test drug in Russia Mikalai 2019-11-15 13:36
- Reference drugs for triple combination test drug in Russia Yura 2019-11-14 09:24
- Reference drugs for triple combination test drug in Russia PharmCat 2019-11-13 21:25