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

posted by Obinoscopy  – USA, 2020-07-18 02:00 (1816 d 22:08 ago) – Posting: # 21736
Views: 10,944

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
23,428 posts in 4,929 threads, 1,691 registered users;
53 visitors (0 registered, 53 guests [including 6 identified bots]).
Forum time: 00:09 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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