Bioequivalence and Bioavailability Forum • Sometimes PK assessors ≈ scientists

Sometimes PK assessors ≈ scientists [Bioanalytics]

posted by Helmut – Vienna, Austria, 2020-07-17 18:11 (1165 d 17:13 ago) – Posting: # 21734
Views: 4,799

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 :-D .

❝ 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…

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Helmut Schütz

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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