Bioequivalence and Bioavailability Forum

Dear All,

I have a question regarding the interpretation of the ICHM13A for the high-risk products. As far as I understood and confirmed by the Q|A, two studies should be performed for high-risk products: One in fed and one in fasting conditions.

Recently (Before the finalisation of the ICHM13A), we performed a study comparing two high-risk products and the reference product should be administered with according to its SPC. Therefore, the study was performed in fed conditions and the BE was concluded.
Following a DCP, the assessor request a study in fasting condition according to the ICHM13A. My question is do we have to demonstrate the BE for this study even if the two products will have to be administered with food in clinical use?
(SPOILER ALERT, we will be not BE in that conditions and most probably we will have a lower BA).

Thanks in advance for your answers!