4.4. Linearity
The linearity of an analytical procedure is defined in terms of its ability to obtain results directly proportional to the concentrations (quantities) of the analyte in the sample within a defined range (ICH, 1995). It is important to note that the linearity criterion is applied to the results, i.e., back-calculated quantities or concentrations, rather than the response signals or instrument response as a function of the dose or quantities.
To illustrate this concept, Program 4.6 performs a linearity assessment by comparing the original concentrations from the ELISA_VS data set to the corresponding back-calculated concentrations obtained in Program 4.5. This program uses the CALC_CONC data set created in Program 4.5. The results ...
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