RSABE with two test products [Design Issues]

posted by Darborn – Japan, 2023-08-23 13:13 (97 d 22:18 ago) – Posting: # 23706
Views: 902

Thank your reply Helmut!

❝ According to ICH M13A you have to exclude treatments (T1 or T2) and perform two separate analyses on the respective others (T1 vs R and T2 vs R). Your design will lead to two partial replicate designs with missing observations (denoted with below):

❝ 1.

T1  R   •   R

❝ R   T1  R   •

❝ •   R   T1  R

❝ R   •   R   T1

❝ 2.

•   R   T2  R

❝ R   •   R   T2

❝ T2  R   •   R

❝ R   T2  R   •

I tried to read your article about replicate crossover, and now I know it is so called "incomplete block design" (am I right?). However, the true nightmare comes, how can I estimate the sample size required for a power of 80%. :confused:
I guess that using the design of 2x3x3 or 2x2x4 in powerTOST is a big NO… :no:

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