Strategies & Considerations for Bio analytical Method Development and Validation using LCMS/MS: a Review

Bioanalysis, employed for the quantitative determination of drugs and their metabolites in biological fluids, plays a significant role in the evaluation & interpretation of bioequivalence, pharmacokinetic (PK) and toxicokinetic studies. The quality of these studies which are often used to support regulatory filings is directly related to the quality of the underlying bioanalytical data. It is essential to employ well-characterized and fully validated analytical methods to yield reliable results which can be satisfactorily interpreted as well as to emphasize that each analytical technique has its own characteristics which will vary from analyte to analyte.