Sequence effect Vs Subject effect? [Study As­sess­ment]

posted by mittyri – Russia, 2019-07-28 15:19 (350 d 22:47 ago) – Posting: # 20457
Views: 2,882

Hi Helmut,

» Since we are in the same boat and out of curiosity: p-values of the sequence effect were given by the CRO and also by the BfArM with 0.0077 (AUC) and 0.0252 (Cmax).
» Recalculated in Phoenix WinNonlin 8.1 and R 3.6.1 (function lm() of stats):
»

PK metric  p (period)  p (sequence)
»   AUC        0.0321      2.42·10–5
»   Cmax       0.0358      2.36·10–5

What‽

which one sequence effect are you referring to?

Kind regards,
Mittyri

Complete thread:

Activity
 Admin contact
20,827 posts in 4,358 threads, 1,449 registered users;
online 27 (2 registered, 25 guests [including 17 identified bots]).
Forum time: 14:07 CEST (Europe/Vienna)

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

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