The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory Original Research Article

On the basis of the guidelines given in the Washington Conference report and the ICH (International Conference of Harmonisation) recommendations some suggestions about experimental design and data evaluation are proposed by an SFSTP Commission dedicated to the validation of chromatographic methods in bioanalysis. In a series of meetings, members of this Commission have tried to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical results generated. This strategy has been formalised in a guide and the main suggestions made by the Commission are summarised in the present paper. The SFSTP guide has been produced to help analysts from the pharmaceutical industry to validate their bioanalytical methods. It is the result of a consensus between professionals having expertise in bioanalytical and/or statistical fields. The suggestions presented in this paper should therefore help the analyst to design and perform the minimum number of validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure. The SFSTP guide suggests a validation strategy in two steps: a pre-validation and the validation itself. An experimental design is described for each of these steps and the main aspects discussed in the paper are related to the selection of the most appropriate calibration model to fit experimental data and the most suitable way to determine the limit(s) of quantitation and subsequently the calibration range as well as the optimum number of experiments to be performed in the validation phase.