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

posted by PharmCat  – Russia, 2019-11-13 21:25 (266 d 17:11 ago) – Posting: # 20801
Views: 2,868

» i.e. 2 tablets. All of these drugs are reference drugs according to the GRLS system.
» What is your opinion which option to choose?


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.

Complete thread:

 Admin contact
20,969 posts in 4,374 threads, 1,460 registered users;
online 16 (1 registered, 15 guests [including 9 identified bots]).
Forum time: Thursday 15:37 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz