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RegisterMinimum required standards [Bioanalytics]
Hello,
As per the FDA guidance for method validation, A calibration curve should consist, among other things, of six to eight non-zero samples covering the expected range, including LLOQ. Furthermore, in the acceptance criteria for the run, they require 75%, or a minimum of six standards meeting acceptance criteria. (75% represents 6 out of 8 calibrants).
My question is: if there are 10 standards in the calibration curve, does the minimum of 6 apply or the 75% which is 8 out of 10 does?
I think that they specified a minimum of 6 because it's 75% of the example they gave which is 8 standards.
Regards.
Geokad
Great job you are doing here.
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Edit: Category changed. [Ohlbe]
As per the FDA guidance for method validation, A calibration curve should consist, among other things, of six to eight non-zero samples covering the expected range, including LLOQ. Furthermore, in the acceptance criteria for the run, they require 75%, or a minimum of six standards meeting acceptance criteria. (75% represents 6 out of 8 calibrants).
My question is: if there are 10 standards in the calibration curve, does the minimum of 6 apply or the 75% which is 8 out of 10 does?
I think that they specified a minimum of 6 because it's 75% of the example they gave which is 8 standards.
Regards.
Geokad
Great job you are doing here.
--
Edit: Category changed. [Ohlbe]
Complete thread:
- Minimum required standardsGeokad 2008-09-30 21:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Minimum required standards Ohlbe 2008-09-30 22:02
- Minimum required standards Helmut 2008-10-01 10:35
- Minimum required standards Geokad 2008-10-01 15:24
- Minimum required standards Helmut 2008-10-01 10:35
- Minimum required standards Ohlbe 2008-09-30 22:02
Ing. Helmut Schütz