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RegisterAcceptance of standard curve and reanalyzed samples [Bioanalytics]
Dear Ken,
If the repeat was for an analytical reason: no. If it was a PK repeat or anomalous value: yes, I would do a 3rd analysis. Or actually, I would rather do the repeat analysis in duplicate.
There is nothing written in any guideline...
You can call it an SOP, or internal guideline, or whatever. But it needs to be defined in writing in advance, in a controlled document which is part of your quality system, with clear decision rules for each type of repeat and the various situations.
❝ Do we need to inject the third time if the repeat value and the initial value are far apart ? I have seen some CROs inject the third time to confirm whether the repeat or the initial value should be picked.
If the repeat was for an analytical reason: no. If it was a PK repeat or anomalous value: yes, I would do a 3rd analysis. Or actually, I would rather do the repeat analysis in duplicate.
❝ How far the difference in value between repeat and initial value to justify for the third injection ?
There is nothing written in any guideline...
❝ How detail we should write in our SOP ? Besides SOP, can we define in in-house guideline ?
You can call it an SOP, or internal guideline, or whatever. But it needs to be defined in writing in advance, in a controlled document which is part of your quality system, with clear decision rules for each type of repeat and the various situations.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Acceptance of standard curve and reanalyzed samples Ken Peh 2014-03-27 19:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Acceptance of standard curve and reanalyzed samples Ohlbe 2014-03-31 10:54
- Acceptance of standard curve and reanalyzed samples Ken Peh 2014-03-31 18:41
- Acceptance of standard curve and reanalyzed samples Ken Peh 2014-04-01 18:36
- Acceptance of standard curve and reanalyzed samplesOhlbe 2014-04-01 19:12
- Acceptance of standard curve and reanalyzed samples Ken Peh 2014-06-23 09:09
- Acceptance of standard curve and reanalyzed samples Ohlbe 2014-07-02 23:21
- Acceptance of standard curve and reanalyzed samples Ken Peh 2014-06-23 09:09
- Acceptance of standard curve and reanalyzed samplesOhlbe 2014-04-01 19:12
- Acceptance of standard curve and reanalyzed samples Ohlbe 2014-03-31 10:54
Ing. Helmut Schütz