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:

Complete thread:

UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,642 registered users;
10 visitors (0 registered, 10 guests [including 3 identified bots]).
Forum time: 10:32 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