ULOQ [Study As­sess­ment]

posted by Ohlbe – France, 2017-10-30 11:35 (2341 d 09:26 ago) – Posting: # 17948
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Dear Anand,

❝ 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

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