PK assessors variability [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-18 01:48 (923 d 20:13 ago) – Posting: # 21735
Views: 4,414

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:

UA Flag
Activity
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
11 visitors (0 registered, 11 guests [including 4 identified bots]).
Forum time: 21:01 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

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