Chapter 6 - Validation of bioanalytical chromatographic methods for the quantification of drugs in biological fluids

Abstract

Abstract Method validation is a mandatory step in bioanalysis to evaluate the ability of developed methods in providing reliable results for their routine application. Even if some organisations have developed guidelines to define the different parameters to be included in method validation (FDA, EMA); there are still some ambiguous concepts in validation criteria and methodology that need to be clarified. The overall validation process including common validation parameters (selectivity, linearity range, precision, accuracy, stability…) will be reviewed with the aim to clarify the methodology to be followed in bioanalytical method validation, facilitating this time consuming step. Therefore, this chapter not only aims to include the most relevant aspects of bioanalytical method validation (BMV), but to help those researchers who do not regularly work on the field face the validation process.