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

posted by PharmCat  – Russia, 2019-11-21 15:02 (1612 d 06:12 ago) – Posting: # 20853
Views: 4,788

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:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,655 registered users;
31 visitors (0 registered, 31 guests [including 3 identified bots]).
Forum time: 22:14 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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