Bioequivalence and Bioavailability Forum

Dear Helmut,

Thank you for the explanation on predose sampling involving endogenous compounds.

If a BE study is planned in the fasted and/or fed state, do we have to consider taking the predose samples in fasted and/or fed state? In one of my fasted study which failed, I found that the predose samples were taken after high fat breakfast!

Kindly help me in understanding the need to have standardization throughtout the study including taking predose samples at fasted state if a fasted BE study is planned.

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