PK assessors variability [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-17 23:48 (508 d 17:00 ago) – Posting: # 21735
Views: 3,613

Hi Ohlbe,

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

:-D

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

Complete thread:

Activity
 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 7 (0 registered, 7 guests [including 2 identified bots]).
Forum time: Wednesday 15:49 CET (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5