crossover design when use RSABE with two test products [Design Issues]

posted by Darborn – Japan, 2023-08-22 04:24 (99 d 07:17 ago) – Posting: # 23704
Views: 1,118

Dear all,

Normally we use 2x3x3 or 2x2x4 replicated design for RSABE, but it needs only one test drug.
When design a crossover trial with two test drug (or one ODT given with/without water), I run into confusion about how to give a balanced design for the trial.
Furthermore, which make things even worse, I always get confused by "variance-balanced" and "carryover-balance" design.

I came out with the following design, but I'm not sure if it is suitable to use when analyzed with FDA RSABE approach.

T1  R   T2   R
R   T1  R   T2
T2  R   T1  R
R   T2  R   T1


Thank you!
Darborn


Edit: Tabulators changed to spaces and BBcoded; see also this post #6[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,642 registered users;
12 visitors (0 registered, 12 guests [including 6 identified bots]).
Forum time: 10:41 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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