drug concentration <LLOQ in both periods [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2009-10-14 15:51 (5747 d 22:09 ago) – Posting: # 4355
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Dear Vidya!

❝ [...] for one subject drug concentration was nil for both periods.


Do you mean <LLOQ?
'Nil' doesn't exist in bioanalytics. :-D

❝ we excluded that subject from stastical analysis.


Sure, what's AUCT/AUCR = 0/0...

❝ How to report same in integrated (clinical) report?


As is. But: try to find an explanation anyhow. Is the drug subjected to polymorphic metabolism? One example is codeine, where besides slow/fast metabolizers there is a rare subpopulation of ultrafast metabolizers. In such a case you simply don't catch the parent with an analytical method validated for a BE-study...

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