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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
Complete thread:
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- Duplicate LLOQ and ULOQOhlbe 2020-05-26 19:43
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- Duplicate LLOQ and ULOQOhlbe 2020-05-26 19:43
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- Deviation from the mean response Helmut 2020-08-07 13:28
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- Broken-stick regression Helmut 2020-08-04 18:04
- Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
- Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
Ing. Helmut Schütz