Subject within sequence effects [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2012-05-02 22:10 (4374 d 15:36 ago) – Posting: # 8494
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Hi Andrew,

❝ However, again for all primary parameters, the P values for subject (sequence) are highly significant.


❝ Can you tell me what, if anything, this might mean?


What you see is that Subjects contribute to "very much" to the variability of your data. This is very often so, because you have different subjects who absorb, distribute, metabolise and eliminate the drug individually and thereby differently. A big person with lots of plasma will -all other factors equal- have low AUC's and Cmax's and vice versa. And so on and so forth. Your observation is a confirmation that all men are not born equal. It does not imply that your study is invalid and it does not affect the conclusion re. bioequivalence.

Pass or fail!
ElMaestro

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