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

posted by PharmCat  – Russia, 2019-11-13 22:25 (1566 d 18:32 ago) – Posting: # 20801
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❝ i.e. 2 tablets. All of these drugs are reference drugs according to the GRLS system.


❝ What is your opinion which option to choose?


Hello!

Strictly for bioequivalence you should chose drug from register that have label "Reference drug". If no such drug - you should make
efficacy trial.

I heard there was a case when drug was registered in EU and BE in Russia was performed with separate reference drugs - but now this case is not approvable, but some companies try to do this.

If say strict - both cases is wrong.

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