Guideline for Russia and Mexico [Regulatives / Guidelines]

posted by munish244 – India, 2012-08-23 10:26 (5059 d 13:05 ago) – Posting: # 9094
Views: 5,092

What is the Bio equivalence criteria for generics drugs in Russia and Mexico (Specifically for highly variable drugs)?
Do we need to conduct the BE study on mexican and russian population only?
Which innovators (reference) products should be used in Mexico and Russia for BE study? Can we make use of US innovator in study in Mexico or Russia?

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,571 registered users;
331 visitors (0 registered, 331 guests [including 14 identified bots]).
Forum time: 23:32 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

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