Reference drugs for triple combination test drug in Russia [Design Issues]

posted by Mikalai  – Belarus, 2019-11-15 13:36 (752 d 02:35 ago) – Posting: # 20805
Views: 4,056

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,

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