Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-06-18 13:14  – Posting: # 20334
Views: 1,572

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').

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

Activity
 Admin contact
20,797 posts in 4,354 threads, 1,445 registered users;
online 16 (0 registered, 16 guests [including 4 identified bots]).
Forum time: 07:47 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

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