Sequence effect Vs Subject effect? [Study As­sess­ment]

posted by mittyri – Russia, 2019-07-28 15:19 (425 d 10:17 ago) – Posting: # 20457
Views: 3,305

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


which one sequence effect are you referring to?

Kind regards,

Complete thread:

 Admin contact
21,076 posts in 4,394 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Saturday 01:36 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

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