From Russia (with love?) [RSABE / ABEL]

posted by PharmCat  – Russia, 2019-12-04 14:16  – Posting: # 20924
Views: 1,243

Hello Helmut!

IMHO, main points:

1. Basic words. Review article.
2. ABEL/RSABE - all have TIE inflation.
3. Biggest inflation when CVintra = 25—30%.
4. EMA aproach better than FDA.

Conclusion:

When you are planning bioequivalence trial better look at EMA guidelines, rather than FDA. We know that all approaches have TIE inflation.

I think this is primarily a message to regulatory experts.

Complete thread:

Activity
 Admin contact
20,346 posts in 4,274 threads, 1,404 registered users;
online 16 (1 registered, 15 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 09:04 UTC

The belief that there is only one truth and
that oneself is in possession of it,
seems to me the deepest root of all
that is evil in the world.    Max Born

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