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

posted by ElMaestro  – Belgium?, 2020-07-20 07:49 (100 d 06:03 ago) – Posting: # 21756
Views: 1,908

Hi obi,

» 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.

If there is an established root cause which can be said to disqualify the initial value, then the (or a) repeat value is the natural value to report (provided of course that the repeat value is in itself considered valid and not suffering the same issue).
When I audit CROs I often encourage dialogue about the distinction between recording a value and reporting a value. It is a bit more than word play.

» 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.

That's right. Even back then, when dinosaurs were roaming the jungle, Lucy was still not born, TV shows about the Kardasians were in black and white, flint axes were popular etc, I was enforcing it that way.
Actually, I can see I make it sound like I was influential and competent. Nothing could be farther from the truth :crying: (and that's still the lamentable state of things, by the way).
I rarely opened the analytical report in dossiers I assessed, but when I on occasion did then repeats (samples, runs or of individual validation tests), deviations, integrations, failed runs, exclusions/inclusion for A&P calculation, and stabilities tended to be the topics that had my attention.

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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