Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-06-18 13:14 (461 d 04:24 ago) – Posting: # 20334
Views: 1,823

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,

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

 Admin contact
21,068 posts in 4,392 threads, 1,466 registered users;
online 20 (1 registered, 19 guests [including 8 identified bots]).
Forum time: Monday 17:38 CEST (Europe/Vienna)

I have finally come to the konklusion
that a good reliable set ov bowels
iz worth more to a man
than enny quantity of brains.    Josh Billings

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