Bioequivalence and Bioavailability Forum • calibration curve range

calibration curve range [Bioanalytics]

posted by wienui – Germany/Oman, 2019-02-20 19:32 (2285 d 01:35 ago) – Posting: # 19945
Views: 5,379
(edited on 2019-02-21 05:30)

❝ Salam Osama,

❝

❝ ❝ In a BE study, the average Cmax of subjects samples was found out of the ULOQ of the calibration curve.

❝

❝ You’ve gotta be kidding! :-D

Salam Helmut,

No, my friend, I hoped I were kidding but unfortunately this is the reality. Moreover, it was given as a justification that samples were reanalyzed after dilution with blank human plasma to bring the analyte concentration into the validated calibration curve range which then multiplied by the dilution factor and reported in the final table of concentrations and that only 5% of subjects'samples have concentrations above ULOQ ( although we speak about the average Cmax!!!)

very nice!!!!
regards,
Osama

—
Cheers,
Osama

Complete thread:

calibration curve range Ladi 2016-02-23 09:22
- calibration curve range ritesh.korat.pharma 2016-02-26 19:35
  - calibration curve range Ladi 2016-03-03 06:02
  - calibration curve range Ohlbe 2016-03-03 16:46
- calibration curve range Ohlbe 2016-03-03 16:41
  - calibration curve range wienui 2019-02-20 18:13
    - calibration curve range Helmut 2019-02-20 18:19
      - calibration curve rangewienui 2019-02-20 18:32