Russia BE Study [Regulatives / Guidelines]

posted by Beholder  – Russia, 2015-03-27 11:21 (2171 d 03:54 ago) – Posting: # 14624
Views: 5,146

»  I. link Russian BE Guideline & Drug data base search(russia)

Actually this GL 2008 from BEBAC library is the old one. I have new GL 2013 but only in Russian.

» II. If the product already available in russia with two marketed players, then BE Study required & has to be performed in Russia.

Yes, you are absolutely right.

Best regards

Complete thread:

 Admin contact
21,371 posts in 4,463 threads, 1,495 registered users;
online 11 (0 registered, 11 guests [including 3 identified bots]).
Forum time: Saturday 15:15 UTC (Europe/Vienna)

If debugging is the process of removing bugs,
then programming must be the process of putting them in.    Edsger W. Dijkstra

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