Bioanalytical Method Development

         

          Method Development

• The purpose of bioanalytical method development is to define the chromatographic conditions, limitations and suitability of the method for its intended purpose and to confirm that the method is optimised for validation. 
• Before the development of a bioanalytical method, analyst should understand the analyte of interest (e.g., the physicochemical properties of the drug, in vitro and in vivo metabolism and protein binding).
• Method development involves optimising the procedures and conditions involved with sample extracting and detecting the analyte. Method development can include the optimisation of the following bioanalytical parameters to ensure that the method is suitable for validation: Reference standards, Specific reagents, Calibration curve standards (CC), Quality control samples (QCs), Selectivity and specificity, sensitivity, accuracy, precision, recovery, stability of analyte in matrix and dilution preparation.
• Once the method has been developed, bioanalytical method validation confirm that method is suitable for study sample analysis.