Bioequivalence and Bioavailability Forum

SOPitis? [Software]

posted by Helmut  – Vienna, Austria, 2014-04-02 13:57 (4463 d 02:41 ago) – Posting: # 12757
Views: 12,795

Dear Fabrice,

I wonder if you are not overdoing standardization. I am definitely a friend of laying down applied methods in the protocol, which – contrary to SOPs – are reviewed by the IEC and approved by an agency, but I think that you are going a little bit too far here. Descriptive statistics of con­cen­trations are as relevant in BE as the listing of anthropometric data of sub­jects.
I would be reluctant to use the term “bias”, since we don’t have good (any?) evidence of the underlying distribution of concentrations. Which location parameter should we use? The arithmetic or geo­metric mean, the median (see this post)?
BTW, most (all?) people connect data points by straight lines. Does that make sense (see this post)?

❝ […] taking a sample 10% before the planned time […]

Sampling too early would ring my alarm bell concerning the proper performance of the clinical part.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

Complete thread:

• WNL, time deviations Beholder 2014-03-25 06:23 
  • Use nominal times fno 2014-03-25 09:47
    • Use nominal times Beholder 2014-03-27 07:50
      • Data binning Helmut 2014-03-27 13:47
        • Data binning Beholder 2014-03-28 08:08
        • Mean concentration curves – which mean #666 d_labes 2014-03-28 11:30
    • Use nominal times AngusMcLean 2014-03-29 13:06
      • Use nominal times mittyri 2014-03-29 14:45
    • Use nominal times mittyri 2014-03-31 20:31
      • Use nominal times fno 2014-04-01 17:48
        • Use nominal times Beholder 2014-04-02 08:23
          • Use nominal times fno 2014-04-02 17:16
        • SOPitis?Helmut 2014-04-02 11:57
          • SOPitis? fno 2014-04-04 09:49
  • WNL, time deviations SDavis 2014-04-24 15:10