Bioequivalence and Bioavailability Forum • Handling "Not Reportable" Data

Handling "Not Reportable" Data [Bioanalytics]

posted by AngusMcLean – USA, 2014-11-28 20:09 (4230 d 23:42 ago) – Posting: # 13954
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it seems to me that the value > 400 WAS discordant with respect to the pharmacoknetic trend of the values prior to it. As such it can be repeated as a pharmacokinetic outlier according to an appropriate SOP. If the two new values for the duplicate repeats carried out are within 20% of each other then according to appropriate SOP then they would be averaged and report this value. The >400 values is rejected as a pharmcokinetic outlier. You need an SOP policy in place to follow and in the analytical report all repeats are Tabulated together with the reason for repeats and final values. This report will reference the Lab. SOPs for repeats

Angus

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" 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" DataAngusMcLean 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