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RegisterReanalysis for PK Reason: Gone with the Wind [Bioanalytics]
Hi obi,
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.
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
(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.
❝ 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
(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.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
- Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 18:39
- Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 19:15
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-16 21:48
- PK assessors variability Ohlbe 2020-07-16 23:07
- Sometimes PK assessors ≈ scientists Helmut 2020-07-17 16:11
- PK assessors variability Obinoscopy 2020-07-17 23:48
- Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-16 23:19
- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-20 07:22
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-20 14:12
- Positive pre-dose Ohlbe 2020-07-20 14:43
- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-20 07:22
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:00
- Reanalysis for PK Reason: Gone with the WindElMaestro 2020-07-20 07:49
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
- Sightly OT (for once) ElMaestro 2020-07-20 12:12
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
- Reanalysis for PK Reason: Gone with the WindElMaestro 2020-07-20 07:49
- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
- PK assessors variability Ohlbe 2020-07-16 23:07
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 18:39
- Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
- Reanalysis for Pharmacokinetic Reason Achievwin 2020-07-27 23:47
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
Ing. Helmut Schütz