Bioequivalence and Bioavailability Forum

Sometimes PK assessors ≈ scientists [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2020-07-17 16:11 (300 d 20:32 ago) – Posting: # 21734
Views: 2,986

Hi Ohlbe,

» There is indeed a high between-subject variability when it comes to PK assessors, sometimes even some within-subject variability, depending on their degrees of freedom .
» In Europe: add the between-country variability.

Perfect description.
Last year I had a discussion with members of an European agency about irregular profiles and exclusion of data. They told me to regularly (‼) accept exclusion of “physiologically not plausible concentrations”. I was surprised and said that it is against the GL. Raised eyebrows…

—
Dif-tor heh smusma 🖖
Helmut Schütz


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Science Quotes

Complete thread:

• Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30 [Bioanalytics] 
  • Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
    • Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
      • Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 18:39
        • Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 19:15
      • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-16 21:48
        • PK assessors variability Ohlbe 2020-07-16 23:07
          • Sometimes PK assessors ≈ scientistsHelmut 2020-07-17 16:11
          • PK assessors variability Obinoscopy 2020-07-17 23:48
        • Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-16 23:19
          • Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
            • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
              • Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-20 07:22
                • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-20 14:12
                • Positive pre-dose Ohlbe 2020-07-20 14:43
          • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:00
            • Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-20 07:49
              • Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
                • Sightly OT (for once) ElMaestro 2020-07-20 12:12
  • Reanalysis for Pharmacokinetic Reason Achievwin 2020-07-27 23:47