Bioequivalence and Bioavailability Forum • Handling "Not Reportable" Data

Handling "Not Reportable" Data [Bioanalytics]

posted by Emrah Soner Özdeş – Turkey, 2014-11-21 09:18 (3840 d 11:39 ago) – Posting: # 13902
Views: 14,543

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:

Obtained study sample concentration is above the ULOQ. Such sample will be diluted with drugfree plasma and re-assayed.
Internal standard and/or analyte response is not sufficient
Fault in the sample processing
Improper sample injection or malfunction of equipment
Poor chromatography
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.

Complete thread:

Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:25
- Handling "Not Reportable" Data ElMaestro 2014-11-21 07:34
  - Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:54
    - Handling "Not Reportable" Data nobody 2014-11-21 08:07
      - Handling "Not Reportable" DataEmrah Soner Özdeş 2014-11-21 08:18
        
        Handling "Not Reportable" Data ElMaestro 2014-11-21 09:53
        Handling "Not Reportable" Data nobody 2014-11-21 11:11
        
        Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 16:14
        
        IS carry-over? Helmut 2014-11-21 16:45
        
        IS carry-over? nobody 2014-11-21 17:19
        IS carry-over? Emrah Soner Özdeş 2014-11-24 08:58
        IS carry-over? Emrah Soner Özdeş 2014-11-27 10:28
        
        Another story! Helmut 2014-11-27 14:21
        
        Another story! Emrah Soner Özdeş 2014-11-28 10:00
        Another story! nobody 2014-11-28 10:18
    - Handling "Not Reportable" Data AngusMcLean 2014-11-28 19:09
      - EMA and similar regulations… Helmut 2014-11-28 19:16
        
        EMA and similar regulations… jag009 2014-12-01 19:54