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

posted by Beholder  – Russia, 2019-11-19 15:39 (1110 d 21:27 ago) – Posting: # 20828
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❝ We don't know nothing about new FDC - no safety, no efficacy data. This is new drug.


Why no safety and efficacy data!? Lets take abovementioned examples:

Amlodipine + Indapamide + Perindopril - here
Losartan + Amlodipine + Rosuvastatin - here.
Indapamide + Rosuvastatin + Perindopril here.

So, can we say that "In all cases, the established regime has a well-characterized safety and efficacy profile..." and proceed with Scenario 2 comparing triple combination with two reference drugs?!

Best regards
Beholder

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