3x3 or 2x4? [RSABE / ABEL]

posted by felipeberlinski – Brazil, 2014-10-22 16:20 (4265 d 19:28 ago) – Posting: # 13763
Views: 19,009

Dear friends

Reading a BE reccomendation of FDA I would like to know about your experience using two different designs.

Since the drug is a HVD:
Their reccomendation is to use a 3-sequence 3-period or a 2-sequence 4 period design.

Could anybody explain the main differences between them and when should I use each one? Go easy, I'm not a biostatistician :cool:

Thanks in advance


Edit: Category changed. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
282 visitors (0 registered, 282 guests [including 11 identified bots]).
Forum time: 11:49 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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