Bioequivalence and Bioavailability Forum

Hi compliance,

❝ Does FDA raise any concern if we get around 20 to 25% positive pre-dose concentration in subsequent period of the study? Please note that the product is long acting depot injection and wash out duration fixed based on the data available on FDA site under SBOA for reference product.

As I see it you would never plan for 20%-25% having predose concentrations. You would plan to avoid it. Therefore, in such a study one might argue that planning had gone not just wrong but badly wrong. This would perhaps not affect the conclusion of BE in the study in question, but one could argue that initiating studies where 20%-25% of subjects are futilely exposed to IMP is an ethical concern. Under some circumstances it could be an inspection trigger.

Send some more info. How did your average apparent Kel look in comparison with SPC /prescr. info? Did you find some other useful explanations yourself?