pre-dose concentrations above LLOQ [Study As­sess­ment]

posted by Ohlbe – France, 2011-12-22 23:06 (4906 d 03:46 ago) – Posting: # 7814
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Dear Paola,

❝ Since we are excluding that the concentration > LLOQ at pre-dose time could be due to bioanalytical issue, we think that the source of the problem could be the contamination of some tubes, probably following the contamination of the head of the pipettes.


Strange. The tubes are usually processed time-point wise. If this is indeed the way your clinic works, all pre-dose samples in Period 1 will have been pipetted before the first post-dose sample was processed. Unless the clinic did another study on the same molecule just before, how did the pipette get contaminated ?

How did you exclude that it was a bioanalytical issue ?

Regards
Ohlbe

Regards
Ohlbe

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