Bioequivalence and Bioavailability Forum

❝ If you plan a cross-over multiple dose study for such a drug, you may consider phenotyping in screening for safety reasons (i.e., include only FMs; otherwise you will end up in toxic range for the PMs). Example: paroxetine.

Dear Helmut,
Thanks for the clarification. Would need one more clarification:

Do we need to carry out Phenotyping for the single-dose, cross-over study also. We are planning to do the single-dose, cross-over BE study for Risperidone Tablets, and we have included phenotyping in this study. The justification provided by the concerned people is "to cancel out the inter-subject variability". But my question is that do we really require phenotyping in this study. Also, if inter-subject variability is a question, it will be taken care of by ANOVA. What do you suggest? Please enlighten.

Regards,
Essar