Bioequivalence and Bioavailability Forum

Dear Martin,

❝ - all concentrations over time are <LOQ for ca. 40% of subjects (no

❝   C_max available)

It is not clear what the purpose of the trial is but I am willing to bet a monthly salary on the fact that the study report when reviewed by an assessor will not do much for you, whatever you do.

The 40% being <LOQ is extremely unexpected unless everybody in your team had had a stroke the day the trial was planned (which I think is unlikely, but feel free to comment).
For this reason, send out an auditor; do a for-cause audit to look at the trial itself and the bioanalysis. Make sure the auditor comes home to give you a really qualified idea of whether the observed problem is a real problem. I highly recommend you to use an auditor that looks for more than just missing signatures or misspelling on training records.