3 period full replicate [RSABE / ABEL]

posted by Dr_Dan  – Germany, 2015-06-24 18:43 (3250 d 19:54 ago) – Posting: # 14978
Views: 29,223

Dear Detlew

❝ The full replicate 3-period design has the sequences TRT / RTR as is stated in your post and of course has T and R replicated. Not in each subject, but if balanced in half of ntotal each. And this design of course allows the evaluation of the intra-subject variabilities of T and R separately.

I think the question is whether a replication in only half of ntotal is sufficient in order to scale or ???

❝ So what's the problem of the "leading European regulatory authority"?

❝ Especially in the light of ElMaestro's remark that only the intra-subject variability of R is of any regulatory concern if scaled ABE is aimed for :confused:.

With regard to ElMaestro's reply: in a former statement the "leading European regulatory authority" had no problem with full replicate design (=4 periods and 6 possible sequences) and half replicate designs (3 periods and 3 sequences). A full replicate 3-period design would not work according to their argumentation since a 3 period design implicity needs 3 sequences.
I do not know why. Maybe you have an idea?
Kind regards

Kind regards and have a nice day

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