Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-17 22:00 (102 d 13:07 ago) – Posting: # 21736
Views: 2,137

Hi ElMaestro,

» PK-repeat analysis may be used as part of a lab investigation, but it still requires a root cause to report a repeat value.

From my understanding of the current thinking of assessors, PK-repeats can be done for lab investigation. However the values are not to be used for pharmacokinetic calculations and Bioequivalence determination.

But, during your enforcing days, PK-repeats can be used for BE determination provided a root cause of the initial result was established, right? If that's true, then I'd say those were the good old days for bioanalytical/pharmacokinetics scientists.

Scopy

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 13 (0 registered, 13 guests [including 4 identified bots]).
Forum time: Wednesday 11:07 UTC (Europe/Vienna)

Actually, science starts to become interesting
only where it ends.    Justus von Liebig

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