Bioequivalence and Bioavailability Forum • crossover design when use RSABE with two test products

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

posted by Darborn – Taiwan, 2023-08-22 04:24 (1038 d 03:41 ago) – Posting: # 23704
Views: 9,211

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:

crossover design when use RSABE with two test productsDarborn 2023-08-22 02:24 [Design Issues]
- RSABE with two test products Helmut 2023-08-23 10:01
  - RSABE with two test products Darborn 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