EVALUATION OF CALIBRATION ROUTINES IN PHARMACEUTICAL AND BIOANALYTICAL SEPARATIONS, WITH REFERENCE TO MONTE-CARLO SIMULATIONS

A Monte Carlo method for the estimation of the bias and inter-assay component of precision attributable to given combinations of assay and calibration routine is described. Simulations are performed by a computer program which uses the actual concentration versus response and concentration versus intra-assay precision characteristics of the assay under investigation as its database. In operation, a calibration routine is selected, the calibrators defined and the analytical process of calibration followed by the analysis of unknowns is reproduced. In this way the mean bias and interassay component of precision at a number of pre-defined concentrations covering the analytical range of the assay is estimated. The program is intended for use by analysts as a practical aid in the selection and optimization of appropriate calibration routines in an experimental environment.