Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2019-06-18 13:14 (619 d 19:11 ago) – Posting: # 20334
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Hi balakotu,

» As per the FDA guidance of Sapropterin Dihydrochloride Tablets, The total dose should be included in the ANOVA model. Please any one suggest the terms should be consider in the ANOVA model, since it is a cross over study.


Thanks for highlighting this.
It is a funny, odd wording. 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').

Pass or fail!
ElMaestro

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