Bioequivalence and Bioavailability Forum

RSABE with two test products [Design Issues]

posted by Darborn – Taiwan, 2023-08-23 13:13 (477 d 00:25 ago) – Posting: # 23706
Views: 3,625

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%. 
I guess that using the design of 2x3x3 or 2x2x4 in powerTOST is a big NO… 

Complete thread:

• crossover design when use RSABE with two test products Darborn 2023-08-22 02:24 [Design Issues] 
  • RSABE with two test products Helmut 2023-08-23 10:01
    • RSABE with two test productsDarborn 2023-08-23 11:13
      • RSABE with two test products: Sample size? Helmut 2023-08-23 11:51
        • RSABE with two test products: Sample size? Darborn 2023-08-30 08:07
    • RSABE with two test products fethiye 2024-02-23 07:14
  • crossover design when use ABEL with two test products BEQool 2024-02-22 09:15
    • crossover design when use ABEL with two test products Helmut 2024-02-23 09:25
      • crossover design when use ABEL with two test products BEQool 2024-02-25 09:59