ULOQ [Study As­sess­ment]

posted by Ohlbe – France, 2017-10-30 11:35 (2368 d 14:21 ago) – Posting: # 17948
Views: 7,986

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

Complete thread:

UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,656 registered users;
109 visitors (0 registered, 109 guests [including 4 identified bots]).
Forum time: 02:56 CEST (Europe/Vienna)

Never never never never use Excel.
Not even for calculation of arithmetic means.    Martin Wolfsegger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5