Validation

The fundamental validation parameters for bioanalytical method validation differ slightly as outlined below. In addition to the assay parameters evaluated during product analysis, bioanalysis essentially investigates how the sample matrix affects the assay read-out. Most importantly, the calibration curve should be prepared in the same biological matrix as the samples by spiking matrix with known concentrations of the analyte. ICH-Quality guidelines are of highest relevance for validation (Q2), stability (Q1) or impurities (Q3).