3 period BE studies, 3 or 6 sequence [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2012-06-07 15:48 (5131 d 06:00 ago) – Posting: # 8670
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Hi John!

❝ For a FDA 3-way BE studies (I know, it's strange), does it matter if I use 3 or 6 sequence?


We had an exhaustive discussion previously. Seems that EMA prefers a 6×3 Williams’ design; FDA no idea.

❝ I plan to go with 3 sequence because I don't want to see a case where 1 sequence ends up with only 1 or 2 subjects due to dropouts […] (Hey people win a lottery sometime)


Hey some people wear their trousers with belts + suspenders. :-D

❝ I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required.


Can’t remember. :-(

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