Bioequivalence and Bioavailability Forum • Reference drugs for triple combination test drug in Russia

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

posted by PharmCat – Russia, 2019-11-21 15:02 (2000 d 22:14 ago) – Posting: # 20853
Views: 8,399

Сomprehensive article:

doi:https://doi.org/10.30895/1991-2919-2019-9-1-14-27

Over the past 10 years some new fixed combinations containing previously registered drugs were approved for use in the Russian Federation based on the results of a single clinical study of bioequivalence in healthy volunteers versus registered monocomponent reference drug. However, this practice does not fully comply with current Russian legislation.

A. V. Dobrovolskiy - Scientific Centre for Expert Evaluation of Medicinal Products ("FGBU")

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