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

posted by PharmCat  – Russia, 2019-11-21 14:02 (788 d 03:39 ago) – Posting: # 20853
Views: 3,797

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")

Complete thread:

Activity
 Admin contact
21,829 posts in 4,566 threads, 1,555 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Monday 17:41 CET (Europe/Vienna)

Discovery consists of seeing what everybody has seen
and thinking what nobody has thought.    Albert Szent-Györgyi

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5