calibration curve range [Bioanalytics]

posted by Ohlbe – France, 2016-03-03 17:41 (2832 d 16:26 ago) – Posting: # 16045
Views: 6,870

Dear Ladi,

❝ My first question is whether this statement is considered acceptance criteria of each analytical run?

Clearly not:

❝ Supposedly, we validated a calibration curve range of 10-100 ng/mL, and LQC is 30, MQC is 50 and HQC is 80 ng/mL. Now please let me set up two scenarios as following.

With just a 10-fold difference between the LLOQ and the ULOQ you're in trouble...

❝ 2) Would you continue with the study or what would you do next?

I would stop and lower the LLOQ to be able to measure concentrations down to 5 % of Cmax... SCNR. I understand that you took this as a theoretical example.

To answer your questions:The idea is that the concentrations of the QC samples should not be totally disconnected from the concentations in the study samples. But the guideline leaves some flexibility.


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