Linearity

Proportional measurement results

Linearity is defined in ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology as, "The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the samples." A methods linearity is its ability to generate test results that are directly proportional to the concentration of analyte in samples within a given range. For analytical method validation linearity must be demonstrated at no less than 5 concentrations ranging between an upper and lower bond of the specification limit (typically LOQ-150%).