Seite - (000107) - in Biomedical Chemistry: Current Trends and Developments

a Limits defined for all calibration standards with exception of LLOQ (in LLOQ ± 20%); b One must correspond to the LLOQ c At LLOQ ± 20% √, Parameter required but its limits are not referenced; LLOQ, Lower limit of quantification; LOD, Limit of detection; NR, Not required; RSD, relative standard deviation (corresponds to the absolute value of coefficient of variation); ULOQ, Upper limit of quantification. During pre-clinical development, bioanalytical data may integrate the regulatory submission process and influence clinical trials design, and, therefore, the method may differ from the original assay of the discovery phase. Frequently, an internal standard (IS) is added to samples in order to compensate errors that can occur during sample preparation and chromatographic analysis, ensuring the reliability of analyte quantification. Validation experiments should be performed maintaining constant IS concentration, where the chromatographic response is given by analyte/IS peak area or height ratio. A stable isotope-labeled derivative of the parent compound is increasingly being