Bioanalytical Method Validation: A Concise Review

Validation of bioanalytical methods includes the performance of all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix (e.g., blood, plasma, serum, or urine) is consistent and reproducible for the intended use. Validation of bioanalytical methods includes the performance of all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix (e.g., blood, plasma, serum, or urine) is consistent and reproducible for the intended use. The bioanalytical validation is divided into 3 types that are Full validation, partial validation, and cross validation. This review consist of evaluation of key parameters of bioanalytical method Accuracy, Precision, Linearity, Selectivity and specificity, Limit of detection, Limit of quantitation, Standard curve (calibration curve), Recovery, Stability, Robustness, and Ruggedness.