Author(s): Hartmann C, SmeyersVerbeke J, Massart DL, McDowall RD
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Abstract A strategy is discussed for the validation of chromatographic methods that are developed to quantify drugs in biological matrices. Both the validation terminology and the hypothesis testing are briefly reviewed. The emphasis is on the design of the experiments required to allow a reliable conclusion about acceptance or rejection of the bioanalytical method. In particular, it is explained how to evaluate the calibration line, devise experiments to estimate precision and bias and how to determine the stability of the analyte between the time of the sample collection and the analysis of the processed sample.
This article was published in J Pharm Biomed Anal
and referenced in Pharmaceutica Analytica Acta