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

posted by PharmCat  – Russia, 2019-12-04 15:16  – Posting: # 20924
Views: 2,194

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.


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:

 Admin contact
20,806 posts in 4,355 threads, 1,447 registered users;
online 19 (2 registered, 17 guests [including 12 identified bots]).
Forum time: 12:47 CEST (Europe/Vienna)

Medical statistician: One who will not accept that Columbus discovered America…
because he said he was looking for India in the trial plan.    Stephen Senn

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