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

posted by BEQool  – 2024-02-22 10:15 (58 d 01:45 ago) – Posting: # 23870
Views: 782

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

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