Study Design- Two treatment or Four treatment [Design Issues]

posted by Relaxation  – Germany, 2023-01-23 17:10 (15 d 09:01 ago) – Posting: # 23435
Views: 374

Hi everybody and ElMaestro.

I thought quite similarly and would use very similar terms.
But re-reading the OP, I have the feeling that the intention may be different and include 4 treatments (?).
For example, sequences could be
A) Test fed - Reference fed - Test fasted - Reference fasted
B) Reference fed - Test fed - Reference fasted - Test fasted.

I have seen such a proposal before (although we were allowed to then "mix" it up and used 4 sequences in the end to also allow assessment of the food effect).

So this would be "a 4 treatment, 2 sequence, 4 period, trial comprising fasted and fed administration" or something similar here.
Or one starts to get creative with "combined 2x2x2 cross-over blocks of fed and fasted adminstration" or something more fitting.
I have no reference for this, its just our house standard to consider each combination of product and administration condition (fed/fast, SD/MD) to be a separate treatment.


Best regards,
Relaxation.

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