Bioequivalence and Bioavailability Forum

PK assessors variability [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-18 01:48 (2170 d 06:14 ago) – Posting: # 21735
Views: 14,486

Hi Ohlbe,

❝ In Europe: add the between-country variability. In the US: possibly a between-review-division variability ?

I wonder the study design we can use to measure these variabilities...especially the variability within the USFDA.

But this is sad...I had thought standardization and uniformity of regulatory review methods should be one of the foundation of regulatory science.

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 ≈ scientists Helmut 2020-07-17 16:11
          • PK assessors variabilityObinoscopy 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