Handling "Not Reportable" Data [Bioanalytics]

posted by Emrah Soner Özdeş – Turkey, 2014-11-21 09:18 (3841 d 17:55 ago) – Posting: # 13902
Views: 14,555

Thanks for reply nobody:

It is apparent that there is a sample processing fault. Here is the related part in the study protocol:

"Individual samples will be re-assayed if at least one of the following criteria is met:
  1. Obtained study sample concentration is above the ULOQ. Such sample will be diluted with drugfree plasma and re-assayed.
  2. Internal standard and/or analyte response is not sufficient
  3. Fault in the sample processing
  4. Improper sample injection or malfunction of equipment
  5. Poor chromatography
  6. Identification of quantifiable analyte levels in pre-dose samples.
The individual samples selected for reanalysis that did not give a valid value (criteria a. – f.) will be reassayed in duplicate if sufficient plasma is available. Initial values, re-assayed results, finally accepted values and a justification for the acceptance will be reported. The individual samples selected for reassay will be assayed in a batch including calibration and QC samples.

I think neglecting that value in PK analysis will be the best practice as ElMaestro advised.

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