Positive pre-dose [Bioanalytics]

posted by Ohlbe – France, 2020-07-20 14:43 (92 d 16:26 ago) – Posting: # 21762
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Dear Dshah,

» Pls note that over here, we are only taking for pre-dose concentration. If the predose concentration>5%, the subject would be excluded from analysis as per most of the guideline.

» I believe that such small change in AUC can be considered non-significant. :-)

The change in AUC is indeed extremely limited, and unless the study outcome is just at the boundary it will indeed not have any influence in itself. But excluding or including a subject, depending on whether his pre-dose concentration is > or < 5% of Cmax, can have dramatic consequences.

Regards
Ohlbe

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