Validation steps and parameters of bioanalytical methods using in clinical studies: A narrative review

Abstract

The bioanalytical method certifications (validation) are very essential for therapeutic drug monitoring. It is critical to use well-defined and completely validated procedures to provide reliable results which can be properly interpreted. This review provides practical steps and procedures with bioanalytical methods validation and highlights chromatographic method validations that have been used in the bioanalysis. It also attempts to clarify the nomenclature of certain stages of bioanalytical validation and to describe the overall process used for the drugs measurement and their metabolites in biological matrices and fluids. The stages of this procedure are discussed and correlated with data of scientific literature. A consistent description of key bioanalytical parameters is discussed and investigated with a view to improve scientific standards of bioanalytical methods used in clinical studies.