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

posted by Obinoscopy  – USA, 2020-07-18 02:00 (1340 d 08:13 ago) – Posting: # 21736
Views: 4,965

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:

UA Flag
Activity
 Admin contact
22,940 posts in 4,812 threads, 1,639 registered users;
45 visitors (0 registered, 45 guests [including 9 identified bots]).
Forum time: 09:14 CET (Europe/Vienna)

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

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