PK assessors variability [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-17 23:48 (193 d 14:30 ago) – Posting: # 21735
Views: 2,386

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.


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