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

posted by PharmCat  – Russia, 2019-11-21 14:02 (914 d 07:40 ago) – Posting: # 20853
Views: 4,029

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
22,092 posts in 4,630 threads, 1,567 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Monday 22:42 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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