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how to define Range and Linearity

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how to define Range and Linearity

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kalidassa
Hi to all can any one explain me how to define Range and Linearity in validation.
Regards
A.Kalidass

Re: how to define Range and Linearity

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Alexandre
Linearity is normally related to a calibration curve, it is a range of concentrations for which the responses can be fitted to a linear function of a certain defined qualities.

Range is the interval of concentrations to which the method is applicable. If the method should give 70-140% recovery and 35% RSD of duplicates, then the range is the interval of concentrations where these characteristics will be routinely achieved all the times, e.g. range - LOD-ULL for Bisphenol A in oil from 10 ppb to 100 ppm by a method “A”.
"If your experiment needs statistics, you ought to have done a better experiment." Rutherford

Re: how to define Range and Linearity

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kalidassa
Thank you for the explanation
Regards
A.Kalidass
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