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

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

posted by BEQool – 2024-02-22 10:15 (846 d 08:18 ago) – Posting: # 23870
Views: 6,522

Hello,
so the most appropriate design for 2 test treatments and replicated reference is a below one?

❝ T1 R T2 R

❝ R T1 R T2

❝ T2 R T1 R

❝ R T2 R T1

Do you think EMA regulators would have any objections if this is was pivotal study (of course bearing Bonferroni adjustment in mind)?

Probably following designs would be worse?:

a) EMA suggested replicate design with additional test treatment

TRR|T2

RTR|T2

RRT|T2

b) 3x6x3 Williams design with additional reference treatment

ABC|C

ACB|C

BAC|C

BCA|C

CAB|C

CBA|C

Best regards
BEQool

Complete thread:

crossover design when use RSABE with two test products Darborn 2023-08-22 02:24
- 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 productsBEQool 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