Bioequivalence and Bioavailability Forum

Dear Nirali!

❝ However as per Canadian guideline, they have recommended RMANOVA with Day and Day*Treatment effects to be considered. Here, I am prefereing to do a ONE WAY ANOVA (as I am considering last three pre-dose).

Have you read my linked slides? The problem with all global assessments is the dichotomous outcome (steady state: yes|no), whereas the regression approach allows exclusion of particular subjects.

❝ Will this approach fulfill the regulatory requirement, as the study is for Europe territory?

Why not? Since there’s no consensus, you must come up with some procedure in the protocol anyhow.
I never had any problems with both of the following methods: Hotelling’s T² and individual regressions.