3 period full replicate [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2015-06-24 16:38 (3219 d 12:35 ago) – Posting: # 14977
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Dear Dr_Dan!

❝ From a leading European regulatory authority I just recieved the information that a 3-period full replicate design (two sequences: T-R-T and R-T-R) for a bioequivalence study will not be accepted. The reason is that for a full replicate design R as well as T need to be repclicated and this is only possible with the respective sequences (so TTRR etc.) ...

Seems the story "Potvin C is not valid in Europe" is duplicated here on another field!

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.

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:.



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