## Dose term in the ANOVA Model [Regulatives / Guidelines]

» » As per the FDA guidance of Sapropterin Dihydrochloride Tablets, The total dose should be included in the ANOVA model.
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» I believe they meant to do an ANCOVA with total dose as covariate.
» Your (fixed) factors would be subject, sequence, period, treatment. Note that even with the bogus random statement in SAS when using PROC GLM the model is fit with a single random term (the 'error').

Dear ElMaestro,

When i keep totaldose is a factor along with normal fixed effects (seq sub(seq) per trt) the model is not execute, Please let us know what are the fixed effects is required in ANOVA model.

SAS code:
model Cmax AUCt AUCi= seq sub(seq) per trt totaldose / ss3; test h= seq e=sub(seq)/htype=3 etype=3;

Regards
Kotu.