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

posted by Obinoscopy  – USA, 2020-07-18 00:00 (186 d 15:31 ago) – Posting: # 21736
Views: 2,355

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
21,308 posts in 4,444 threads, 1,489 registered users;
online 12 (2 registered, 10 guests [including 8 identified bots]).
Forum time: Wednesday 14:32 CET (Europe/Vienna)

Power: That which is wielded by the priesthood of
clinical trials, the statisticians, and a stick which they use
to beta their colleagues.    Stephen Senn

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