Bioequivalence and Bioavailability Forum • 20% of randomly chosen chromatograms

20% of randomly chosen chromatograms - In any Guideline? [Bioanalytics]

posted by ElMaestro – Belgium?, 2018-06-03 19:16 (873 d 21:01 ago) – Posting: # 18848
Views: 5,103

Hi Obi,

» Is the requirement for randomly selecting 20% Chromatogram in any Guideline?

It is in the guidelines to the same extent as the requirement for cherry-picking the 20%.

Make sure to have an SOP which gives an objective way to select them.

—
I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

Selection of chromatograms and its programme Pandu 2009-02-23 14:00 [Bioanalytics]
- 20% of randomly chosen chromatograms Helmut 2009-02-23 15:36
  - 20% of randomly chosen chromatograms Pandu 2009-02-24 06:08
  - 20% of randomly chosen chromatograms Obinoscopy 2018-06-03 18:14
    - 20% of randomly chosen chromatograms - In any Guideline?ElMaestro 2018-06-03 19:16
      - 20% of randomly chosen chromatograms - In any Guideline? Obinoscopy 2018-06-03 22:50
        
        20% of randomly chosen chromatograms - In any Guideline? ElMaestro 2018-06-04 10:51
- Selection of chromatograms and its programme chiragkhatri 2009-02-24 09:17
  - Selection of chromatograms and its programme Pandu 2009-02-24 10:16
    - Selection of chromatograms and its programme krish3108 2009-03-03 09:10
      - Selection of chromatograms and its programme Pandu 2009-03-04 08:31
        
        Equal chance to every one d_labes 2009-03-04 12:15
        
        Equal chance to every one Helmut 2009-03-04 12:51
        
        Orphans, hats, bowls and urns d_labes 2009-03-04 13:20
        
        Equal chance to every one ElMaestro 2009-03-05 20:43
        
        NLYWs d_labes 2009-03-06 10:02