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

On the basis of the guidelines given in the Washington Conference report an d the ICH (International Conference of Harmonisation) recommendations some suggestions about experimental design and data evaluation are proposed by a n SFSTP Commission dedicated to the validation of chromatographic methods i n bioanalysis. In a series of meetings, members of this Commission have tri ed to elaborate a rational, practical and statistically reliable strategy t o 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 bioanalyti cal methods, It is the result of a consensus between professionals having e xpertise in bioanalytical and/or statistical fields. The suggestions presen ted in this paper should therefore help the analyst to design and perform t he minimum number of validation experiments needed to obtain all the requir ed information to establish and demonstrate the reliability of its analytic al procedure. The SFSTP guide suggests a validation strategy in two steps: a pre-validation and the validation itself. An experimental design is descr ibed for each of these steps and the main aspects discussed in the paper ar e 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 q uantitation and subsequently the calibration range as well as the optimum n umber of experiments to be performed in the validation phase. (C) 1999 Else vier Science B.V. All rights reserved.