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RegisterAcceptance of standard curve and reanalyzed samples [Bioanalytics]
Dear Ohlbe,
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. How far the difference in value between repeat and initial value to justify for the third injection ?
How detail we should write in our SOP ? Besides SOP, can we define in in-house guideline ?
Appreciate your comments.
Thank you.
Regards,
Ken
❝ It depends what the reason was to reanalyse the sample. Analytical reason : if you consider the first value to be unreliable, pick the repeat value, even if close to the initial value. For PK repeats or confirmation of weird data (not to be done for EU submissions): you can keep the initial concentration if confirmed by the second.
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. How far the difference in value between repeat and initial value to justify for the third injection ?
❝ In any case the decision tree should be well defined in your SOP, or you could be accused of cherry picking.
How detail we should write in our SOP ? Besides SOP, can we define in in-house guideline ?
Appreciate your comments.
Thank you.
Regards,
Ken
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 samplesKen Peh 2014-04-01 18:36
- Acceptance of standard curve and reanalyzed samples Ohlbe 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 samples Ohlbe 2014-04-01 19:12
- Acceptance of standard curve and reanalyzed samples Ohlbe 2014-03-31 10:54
Ing. Helmut Schütz