Bioequivalence and Bioavailability Forum

Dear Mikkabel,

❝ We will indeed try to answer that the study was performed according to the guideline in force at that time but not sure it will convince the assessor

Not just "at that time": still today. What matters actually is not which guideline was in force when you did the study, but when you submitted the marketing authorisation application, according to the introduction of Annex I to Directive 2001/83/EC.

❝ To be honest, I still not understand why we should be BE in fasting condition if the products should be taken with food in clinical practice.

Well... The problem is, whatever instructions they receive, you have absolutely no control over what the patients will do in real life, and what type of food they will be taking the product with if any: light breakfast (coffee and a slice of bread), or a full fatty lunch ? A fasting study represents the worst case scenario.