Bioequivalence and Bioavailability Forum • 20% of randomly chosen chromatograms

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

posted by Obinoscopy – USA, 2018-06-04 00:50 (2146 d 17:20 ago) – Posting: # 18850
Views: 7,255

Hi ElMaestro,

Thanks for your response.

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

Lol @ cherry-picking. But yeah, that should be a concern for the Sponsor or even the Regulator as the CRO site could cherry-pick runs of samples with wonderfully looking Chromatogram. However I noticed the FDA Guideline did state that chromatogram for NDAs and BLAs be randomly selected while chromatogram for ANDAs be serially selected. Which is great. I hope EMA considers this in subsequent reviews.

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

Yea, the draft FDA Guideline did state that. But it was not stated in the final FDA guideline.....strange.

Regards,

—
Scopy

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