Subject within sequence effects [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2012-05-02 22:10 (5153 d 05:21 ago) – Posting: # 8494
Views: 8,031

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

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
154 visitors (0 registered, 154 guests [including 64 identified bots]).
Forum time: 03:32 CEST (Europe/Vienna)

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5