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RegisterPK assessors variability [Bioanalytics]
Hi Ohlbe,
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.
❝ 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.
—
Scopy
Scopy
Complete thread:
- Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
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Ing. Helmut Schütz