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

posted by Darborn – Japan, 2023-08-22 04:24 (296 d 09:17 ago) – Posting: # 23704
Views: 2,730

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!

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

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