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

posted by Beholder  – Russia, 2019-11-14 11:51 (1611 d 01:22 ago) – Posting: # 20803
Views: 5,099

Hi PharmCat!

❝ Strictly for bioequivalence you should chose drug from


Yes, all above mentioned drugs are marked as reference drugs according to the register, i.e. three monodrugs from option 1 and FDC+monodrug from option 2.

❝ If say strict - both cases is wrong.


Why second is wrong? I have just found quite fresh and approved study with similar situation regarding reference drugs.

Best regards
Beholder

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