Bioequivalence and Bioavailability Forum

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

posted by ElMaestro  – Denmark, 2018-06-04 12:51 (2942 d 08:00 ago) – Posting: # 18852
Views: 11,240

Hi Obi,

❝ ❝ 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.

Isn't this to some extent to the wrong philosophy? Those chromatograms are an essential part of your submission, so of course the matter should be covered by an SOP, whether or not the need for an SOP is stated explicitly in the guidance. I see it that way.

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