Bioequivalence and Bioavailability Forum

❝ @Silva: Is this was you are planning?

Many thanks to both El Maestro and Helmut for the rapid input.

@Helmut, my plans were actually to breath some enriched air! Maybe I could become smarter!! But for now I need to have this question clarified in my mind!

According to PI, it is a "dose finding" study for a new route of adm. PI pretends to start with the Ref injection dose and then study the other route. All subjects will perform all study treatments (all planned doses), unless safety concerns. It is an exploratory study, not a true bioequivalence study.

I agree with you that it is a "paired study" and not a common "crossover study". Facing dosing administration procedure, what would be the ANOVA model: Treatment (dose normalized parameters)+Subject?

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]