Bioequivalence and Bioavailability Forum

Hi Silva,

❝ @Helmut, my plans were actually to breath some enriched air! Maybe I could become smarter!!

Nitrox in Porto Santo?
I love this stuff when diving in “special” conditions. Headaches from Vinho Verde Tinto gone in minutes. Beware of the “virtual bottom” by p_O2!

❝ 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.

OK, makes sense. Haven’t thought of it. Dose escalation studies can’t be done in a crossover.

❝ Facing dosing administration procedure, what would be the ANOVA model: Treatment (dose normalized parameters)+Subject?

Yep. Then the PEs will give you the F_abs for each dose level.

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PS: Can you send me your mobile No (in case I’ll be arrested for misbehavior in my forthcoming vacation and need help).