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RegisterReanalysis for PK Reason: Gone with the Wind [Bioanalytics]
Hi Obi,
What I was enforcing back in my day (roughly 200 million years ago), and what I think it still widely accepted, is not so complicated but perhaps convoluted: PK-repeat analysis may be used as part of a lab investigation, but it still requires a root cause to report a repeat value. A root cause is not a statistical figure but something tangible that proves that the original value is not indicative of the concentration in the sample. Whatever the result of a repeat sample is, that in itself is not a root cause.
Some CROs/labs have elaborate schemes with samples being flagged for repeats if they are out of expectation by some objective or subjective measure, and then three repeats are done, and we enter a decision scheme involving a comparison of the original value with the mean or median of the three repeats in the absence of a root cause. That is not at all universally agreed upon as ideal, I think.
❝ Besides non-BE studies, I also noticed that reanalysis to confirm the presence of the analyte in a pre-dose sample is allowed by some BE assessors. Do you think those group of BE assessors are inconsistent? I ask this because, the same assessors will not accept reanalysis of post-dose samples to correct an irregular PK profile.
What I was enforcing back in my day (roughly 200 million years ago), and what I think it still widely accepted, is not so complicated but perhaps convoluted: PK-repeat analysis may be used as part of a lab investigation, but it still requires a root cause to report a repeat value. A root cause is not a statistical figure but something tangible that proves that the original value is not indicative of the concentration in the sample. Whatever the result of a repeat sample is, that in itself is not a root cause.
Some CROs/labs have elaborate schemes with samples being flagged for repeats if they are out of expectation by some objective or subjective measure, and then three repeats are done, and we enter a decision scheme involving a comparison of the original value with the mean or median of the three repeats in the absence of a root cause. That is not at all universally agreed upon as ideal, I think.
—
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 WindElMaestro 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 Wind ElMaestro 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 Wind ElMaestro 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