Bioequivalence and Bioavailability Forum

Dear Helmut,

❝ • A compromise would be normal meals during saturation phases and the same (high-fat) meal like in the single dose study on profile days.[/list]Why EMA decided to suggest normal meals throughout the entire study remains a mystery. We are all waiting since last November for the PKWP’s comments to be published. Promised for “the next week” a couple of times (Amsterdam March, London April, Budapest May)…

I am going through EMA's website and searching for comments on GL for modified release dosage form. But could not get it. Whether they published comments or not? Have you received it?

Presently, I am designing fed MD study for a prolonged release formulation. Should I go for normo-caloric meals (rather than high fat meal) throughout the study including profiling day. This will comply with present GL, right?

Thank you very much in advance.

MMW