Bioequivalence and Bioavailability Forum

Hi Essar!

OK, risperidone shows polymorphism, so probably you will see a wide range of plasma concentrations in your study. If you perform phenotyping, you will have an explanation for high (PM) and low concentrations (EM), but it does not...

❝ "cancel out the inter-subject variability"

You are exactly right that...

❝ inter-subject variability will be taken care of by ANOVA

So phenotyping is not necessary; it only gives you insights on the distribution of poor and extensive metabolizers in your study (which you don't need in BE assessment).