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RegisterULOQ [Study Assessment]
Dear Anand,
You should dilute further, till you get a result below your ULOQ. If this requires a dilution factor greater than what you tested during validation, then you need to do a partial validation with a greater dilution factor. If you have many results above the ULOQ you may wish to consider to expand your calibration range with a partial validation.
You can't exclude subjects or data points because they are ULOQ: the ULOQ result would be the Cmax for that subject. If you exclude the data, you will bias the outcome of the study.
❝ After Dilution also it found ULOQ.
❝
❝ Method should be redeveloped or revalidated?
You should dilute further, till you get a result below your ULOQ. If this requires a dilution factor greater than what you tested during validation, then you need to do a partial validation with a greater dilution factor. If you have many results above the ULOQ you may wish to consider to expand your calibration range with a partial validation.
You can't exclude subjects or data points because they are ULOQ: the ULOQ result would be the Cmax for that subject. If you exclude the data, you will bias the outcome of the study.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- ULOQ Anand 2017-10-30 06:38 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ULOQ Helmut 2017-10-30 10:30
- ULOQOhlbe 2017-10-30 10:35
- ULOQ Helmut 2017-10-30 10:59
- ULOQ Ohlbe 2017-10-30 15:10
- Not excluding invalid data? Helmut 2017-10-30 17:34
- Excluding invalid data Ohlbe 2017-10-30 18:03
- Not excluding invalid data? Helmut 2017-10-30 17:34
- ULOQ Ohlbe 2017-10-30 15:10
- ULOQ Helmut 2017-10-30 10:59
- ULOQ ElMaestro 2017-10-30 13:18
- Serial dilutions? Don’t! Helmut 2017-10-30 17:53
Ing. Helmut Schütz