Bioequivalence and Bioavailability Forum

Dear Dixit:

I am totally agreed with the recommendation of stated by Torn by EMEA for the fed study "For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions".
As per my experiences the fed study is not required for EMEA only when there is a statement in the Posology that the drug can be taken with or without food.
Since in the SPC of the Mobiflex this statement is not present and in the pharmacokinetics it has been clearly mentioned that the “Concomitant food reduces the rate, but not the extent, of absorption of Mobiflex”.
So as per my opinion you have to perform both the fasting and fed study.

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]