Validating vs. WinNonlin... [🇷 for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2010-04-24 02:28 (5114 d 22:26 ago) – Posting: # 5208
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Dear bears!

❝ Just like analyzing a replicate crossover. I can not find the results obtained from analyzing with WinNonlin using a linear mixed effects model. As far as I could remember, we got pretty similar results as with WinNonlin at that moment.


D. Labes referred to one of my old posts: WinNonlin's method (assuming equal variances) is flawed - even in the current releases WinNonlin 5.3 and Phoenix/WinNonlin 6.1. The model is equivalent to the common one-way ANOVA (but like everything in WinNonlin based on maximum likelihood); only one fixed effect = treatment (no random subject term whatsoever). A random subject term does not make sense IMHO.

❝ Which model is more appropriate for analyzing parallel BE study with R?


Agreeing with D. Labes in the top post I would also use a t-test for unequal variances. That's the default of t.test and in conformity with FDA's requirements. For simple code see the subsequent post in the quoted thread.

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