Bioequivalence and Bioavailability Forum

Hi Mohamed,

❝ I am writing from Egypt […] this apparently came from a new member who joined the BE Evaluation committee.

… who apparently has not completed his training yet. SCNR.

❝ I welcome other comments from members.

I fully agree with Ohlbe. In assessing (in)accuracy/(im)precision of bioanalytical methods we are only interested in back-calculated concentrations. Haven’t seen anything else in 30+ years.

Since you wanted a reference, see how the EMA’s BMV-GL defines the LLOQ:

The lower limit of quantification (LLOQ) is the lowest concentration of analyte in a sample which can be quantified reliably, with an acceptable accuracy and precision.

See also what the GL says about the calibration curve and accuracy.
(Back calculated) concentrations. Period.