Winnonlin: exclude incomplete data! [Software]

posted by Helmut Homepage – Vienna, Austria, 2014-01-10 14:41 (4542 d 08:06 ago) – Posting: # 12155
Views: 19,783

Hi mittyri,

❝ ❝ […] Since Phoenix/WinNonlin only speaks REML, you have to exclude incomplete data. […] you have to filter for complete data in Phoenix first. Otherwise you are in mixed-effects model limbo.


❝ In the study we have 2 volunteers who were discontinued the study after 1st period (both from same sequence)

❝ Do I understand correct, that I shouldn't put the data from these subjects to WNL?


Yes. See also the EMA’s GL:

[…] subjects in a crossover trial who do not provide evaluable data for both of the test and reference products […] should not be included.


❝ I tried both options (with and without them) and recieved unequal CIs


Correct. PHX/WNL in its default setting (incomplete data included) will recover information of the between-subject variance (REML estimate of a mixed-effects model). In SAS-speak that’s Proc MIXED instead of Proc GLM. In other words, the variance will be differently split into their between-, within-, and residual components. Therefore, the CI (and CVintra) will be affected as well – though in my experience the difference generally is quite small.
See also an example in SAS 9.2 and WinNonlin 5.2.1.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
241 visitors (0 registered, 241 guests [including 134 identified bots]).
Forum time: 23:48 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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