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RegisterDuplicate LLOQ and ULOQ [Bioanalytics]
Dear Helmut,
Some just picked the one they liked best. I heard they ran into trouble
Most frequent: use the first result only. If, and only if it fails (more than 20% deviation at the LLOQ, 15% at the ULOQ): exclude it and use the second. The aim being of course to avoid having to truncate the curve in case of failure.
I see this less and less often. Not sure why (guess: some FDA inspectors did not like it).
❝ ❝ (in the past many labs analysed the LLOQ and ULOQ samples in duplicate, with only one of the results being used following an SOP, but all others were singlets).
❝
❝ I see. How does such an SOP look like? Pick out the best?
Some just picked the one they liked best. I heard they ran into trouble
Most frequent: use the first result only. If, and only if it fails (more than 20% deviation at the LLOQ, 15% at the ULOQ): exclude it and use the second. The aim being of course to avoid having to truncate the curve in case of failure.
I see this less and less often. Not sure why (guess: some FDA inspectors did not like it).
—
Regards
Ohlbe
Regards
Ohlbe
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Ing. Helmut Schütz