Bioequivalence and Bioavailability Forum

Handling "Not Reportable" Data [Bioanalytics]

posted by nobody – 2014-11-21 09:07 (3841 d 17:16 ago) – Posting: # 13901
Views: 14,523

Educated guess, considering the values reported: The first concentration did not fit considering the PK of the compound

Maybe the lab staff screwed a little up with pipetting or there was something else leading to a contamination of the first analysis. What does the SOP of the CRO say for such a case? Completely ignore the plausible 2 repeats?

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" Datanobody 2014-11-21 08:07
        • Handling "Not Reportable" Data Emrah 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