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RegisterReference drugs for triple combination test drug in Russia [Design Issues]
Hi Beholder,
The best approach is to speak with the regulator. We are discussing polypills which, in my opinion, should be registered for the first time after phase trials as reference drugs not after BE ones. The BE trials can be conducted when regulators have access to full dossiers of the reference drugs. The question is whether there is a reference drug with the three APIs in one tablet? If yes, then just proceed with a BE trial, if not then it is better to speak with the regulator. I know that in Russia as well as in Belarus very questionable products can be registered based on very questionable approaches. Also, there is a question about whether the sponsor plans to market the drug abroad?
Best regards,
The best approach is to speak with the regulator. We are discussing polypills which, in my opinion, should be registered for the first time after phase trials as reference drugs not after BE ones. The BE trials can be conducted when regulators have access to full dossiers of the reference drugs. The question is whether there is a reference drug with the three APIs in one tablet? If yes, then just proceed with a BE trial, if not then it is better to speak with the regulator. I know that in Russia as well as in Belarus very questionable products can be registered based on very questionable approaches. Also, there is a question about whether the sponsor plans to market the drug abroad?
Best regards,
Complete thread:
- Reference drugs for triple combination test drug in Russia Beholder 2019-11-13 12:47 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 RussiaMikalai 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
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- Reference drugs for triple combination test drug in Russia Beholder 2019-11-18 10:13
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- 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 Russia mittyri 2019-11-15 23:29
- Reference drugs for triple combination test drug in RussiaMikalai 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
Ing. Helmut Schütz