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

posted by Obinoscopy  – USA, 2020-07-18 00:00 (25 d 22:49 ago) – Posting: # 21736
Views: 1,660

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.


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