Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-06-18 13:14  – Posting: # 20334
Views: 528

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,567 posts in 4,150 threads, 1,341 registered users;
online 12 (1 registered, 11 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 10:30 CEST

Power. That which statisticians are always calculating
but never have.    Stephen Senn

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5