ULOQ [Study As­sess­ment]

posted by Ohlbe – France, 2017-10-30 10:35  – Posting: # 17948
Views: 6,257

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.


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