Bioequivalence and Bioavailability Forum

Good morning folks of BEBAC,

Does anyone know if the EMA has ever accepted the results of a pilot study to access bioequivalence of formulations? For example, lets say we conducted a pilot study in 16 volunteers and the results were within the accepted confidence intervals (and everything else was according to the effective guidelines at the time and it was prespecified in the protocol that the results may be used to access bioequivalence), can this study be considered by the authorities? Specifically, EMA (I believe the FDA has addressed this specifically in their guideline and it's okay with them). Does anyone know of a case where a company has done this is the past with the EMA (in order to have a precedent). And if so, any idea what the product and company is?

Do I make sense?

Thank you in advance.