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RegisterChoose and Pick in method validation [Bioanalytics]
Dear Ken,
If your run still passes for precision and accuracy: just report it, everything is fine. Nobody ever said that each and every individual value in the run had to pass.
If the run fails for precision and/or accuracy: repeat it, but report the failed run in your validation report too. These will be considered as too independent runs (no pooling !). The FDA and EMA will ask you to calculate the global precision and accuracy with all runs, whether passing or failing.
If another run fails: revise your method.
If your run still passes for precision and accuracy: just report it, everything is fine. Nobody ever said that each and every individual value in the run had to pass.
If the run fails for precision and/or accuracy: repeat it, but report the failed run in your validation report too. These will be considered as too independent runs (no pooling !). The FDA and EMA will ask you to calculate the global precision and accuracy with all runs, whether passing or failing.
If another run fails: revise your method.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Choose and Pick in method validation Ken Peh 2013-11-24 04:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Choose and Pick in method validation Ohlbe 2013-11-24 22:45
- Choose and Pick in method validation Ken Peh 2013-11-26 13:37
- Choose and Pick in method validationOhlbe 2013-11-26 18:45
- Choose and Pick in method validation Ken Peh 2013-11-26 13:37
- Choose and Pick in method validation Ohlbe 2013-11-24 22:45
Ing. Helmut Schütz