A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION
In this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should be
applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their
metabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic
studies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigated
to decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of set
up to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass
spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic
methods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy,
precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed
to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug,
concentration and its metabolite.
Keywords: Method development, Clinical and nonclinical study, Analyte, Validation of bioanlysis techniques, Validation parameter.
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