Michał Kaza, Anna Szlagowska, Piotr Rudzki
Walidacja metod bioanalitycznych stosowanych w badaniach farmakokinetycznych
Validation of bioanalytical metods in pharmacokinetic studies. Validation process demonstrates that a particular method used for quantitative measurement of analytes is reliable and reproducible for the intended use. In case of pharmacokinetic studies correctly planed and performed validation increases safety of patients after administration of pharmaceuticals. During the pharmacokinetic evaluation, the important role of bioanalytical procedures, i.e. the quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma or urine, should be stressed. In an article recommended range of bioanalytical method validation was characterized including detailed description of the elementary parameters. Acceptance criteria of validation in accordance with EMEA and FDA guidances were described as well.
Keywords: validation, bioanalytical method, bioavailability, bioequivalence, pharmacokinetics, biological matrix.