EMA Steady State Fed Study breakfast [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-08-23 20:14 (2409 d 02:47 ago) – Posting: # 17745
Views: 4,978

Hi MMW,

❝ ❝ […] 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?


Do you really still hope that – after more than two years of broken promises – the comments will ever be published? C’mon!

❝ […] I am designing fed MD study for a prolonged release formulation. Should I go for normo-caloric meals […] throughout the study including profiling day. This will comply with present GL, right?


If (!) administration in fed state is recommended in the SmPC of the originator, yes.
If not (the SmPC allows fasting or fed), no idea. Too bad, that we don’t have the comments for clarification. In the SD study testing the food effect a high-fat high-calory meal is mandatory. What if an assessor wants the same on profile days? No idea. If you prefer to wear a belt plus suspenders, opt for a scientific regulatory advice.

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