calibration curve range [Bioanalytics]

posted by Ohlbe – France, 2016-03-03 17:46 (2832 d 15:10 ago) – Posting: # 16046
Views: 6,870

Dear Ritesh Korat,

❝ Firstly monitor around 20% of first subject of the study.

Why wait till 20 %, if it is already visible after 2-3 runs that the concentrations are lower than expected ?

❝ if Cmax of both period in 14 (67% of 20) subjects out of that 20 subjects cross two QC level than no need of additional QC

Why 67 % ? Where did you take that figure from ?

IMHO what's important is not just how many subjects have a Cmax below the MQC sample - but also how much below it is.

❝ and if its not than add one more QC between LQC and MQC.

Or adjust the concentration of the existing MQC. The guidelines also gives this option.


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