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RegisterMinimum required standards [Bioanalytics]
Dear Geokad,
My interpretation would be 75 % or 6, whichever is greater (or 75 %, with a minimum of 6).
If you have 6 to 8 calibration samples in your curve: at least 6 should pass. If you have 12 calibration samples: at least 9 should pass.
The problem comes with how to interpret the guidance when 75 % gives you decimals: 75 % of 10 is 7.5, should you go for at least 7, or at least 8 ? I guess the FDA would say at least 8...
Thanks !
Regards
Ohlbe
My interpretation would be 75 % or 6, whichever is greater (or 75 %, with a minimum of 6).
If you have 6 to 8 calibration samples in your curve: at least 6 should pass. If you have 12 calibration samples: at least 9 should pass.
The problem comes with how to interpret the guidance when 75 % gives you decimals: 75 % of 10 is 7.5, should you go for at least 7, or at least 8 ? I guess the FDA would say at least 8...
❝ Great job you are doing here. 
Thanks !
Regards
Ohlbe
Complete thread:
- Minimum required standards Geokad 2008-09-30 21:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Minimum required standardsOhlbe 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 standardsOhlbe 2008-09-30 22:02
Ing. Helmut Schütz