Bioequivalence and Bioavailability Forum • Handling "Not Reportable" Data

Handling "Not Reportable" Data [Bioanalytics]

posted by ElMaestro – Denmark, 2014-11-21 08:34 (3842 d 13:19 ago) – Posting: # 13899
Views: 14,626

Hi Emrah,

❝ "This was a repeat value where the duplicate repeats were more than 20 percent different from one another and also differed from the original. Therefore according to the SOP it becomes Not Reportable."

Why was it re-analysed ?

❝ Do you think is it safe to simply ignore that value during the PK analysis ?

Yes; it is likely safest, I think, to report the original value unless there is some other reason to consider the original value wrong.

—
Pass or fail!
ElMaestro

Complete thread:

Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:25
- Handling "Not Reportable" DataElMaestro 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" 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