Excluding invalid data [Study As­sess­ment]

posted by Ohlbe – France, 2017-10-30 18:03  – Posting: # 17956
Views: 5,652

Hi Helmut,

» What do you think a regulator would prefer?
  1. Excluding the subject and assess BE based on valid data only.
  2. Keep the subject though the reanalysed Cmax in one period is not valid.

Please don't misunderstand what I mean. I'm certainly not pleading to use data which were not demonstrated to be valid during method validation. I would not extrapolate above the ULOQ and I would not analyse a sample beyond its stability period. But let me play the devil's advocate too. Let's imagine your subject had a Cmax at midrange of the calibration curve in Period 1 and is at least 5 x ULOQ in Period 2 (still ULOQ after a 1/5 dilution). Regulators would not be happy with the exclusion of the subject. Which doesn't mean that they would like possibly unreliable data to be used instead: rather that they may reject the study as a whole :-(. Regulators don't wear Armani suits.

OK, we're discussing rather extreme situations. Let's remain optimistic and hope that Anand still has enough plasma for re-analysis, that the analyte is stable, and that the validation of the higher dilution factor will pass :-)


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