FDA guidance for bioanalytical run [Regulatives / Guidelines]
I need your your help with the followings:
Regarding bioanalytical run, EMA states the following:
If the rejected calibration standard is the LLOQ, the LLOQ for this analytical run is the next lowest acceptable calibration standard of the calibration curve. If the highest calibration standard is rejected,the ULOQ for this analytical run is the next acceptable lower calibration standard of the calibration curve. The revised calibration range must cover all QC samples (low, medium and high).
Does this apply for FDA submissin, meaning:can we exclude the ULOQ and the LLOQ from calibration range ?