ANOVA fixed and random effects [General Sta­tis­tics]

posted by Babe_Ruth – USA, 2019-02-08 18:32 (1022 d 06:05 ago) – Posting: # 19889
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What's the appropriate ANOVA model for a two treatment, two period, fixed sequence study?

It's a food effect study where the subject takes the study drug under fasted conditions, 14-day washout, then takes study drug under fed conditions. The proposed is ANOVA model is to analyze log-transformed Cmax and AUClast with terms for treatment condition (Fasted and Fed) as a fixed effect and subject as a random effect.

Is this appropriate, and why or why not?

Compared to the standard 2x2 crossover study, what are the limitations of the above study design in terms of assessing inter- and intra-subject variability?

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