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An Overview of the Development and Validation of Bioanalytical Methods and Their Use in Pharmacy

Author(s) Mayur S. Ingle, Shraddha K. Khatri, Dr. Balaji N. Thakare, Dr. Kailash Biyani
Country India
Abstract According to this review article, bioanalytical techniques are frequently employed to measure medications and their metabolites in plasma matrices, and these techniques ought to be used in both nonhuman and human clinical research. Drugs and their metabolites are quantitatively estimated using a bioanalytical approach in biological media, which is crucial for estimating and interpreting pharmacokinetic, toxicokinetic, and bioequivalence data research. Sample analysis, method development, and method validation are the main bioanalytical functions. To determine the degree to which environmental, matrix, or procedural factors may impede the estimation of analyte in the matrix from the time of setup until the time of analysis, each stage in the procedure must be examined. Drugs in the body can be bioanalyzed using methods like liquid chromatography combined with double mass spectrometry (LCMS-MS) and high pressure liquid chromatography (HPLC). Every instrument has advantages and disadvantages of its own. The bioanalysis of small and big compounds using LC/MS/MS has been the primary application of chromatographic techniques such as gas chromatography and HPLC. Accuracy, Linearity, Among the often utilized parameters are precision, selectivity, sensitivity, repeatability, and stability. We suggest adding additional information about the development and validation parameters of bioanalytical methods in this review article. This would help with quality assurance in determining the drug, concentration, and its metabolite.
Field Medical / Pharmacy
Published In Volume 16, Issue 2, April-June 2025
Published On 2025-04-17
Cite This An Overview of the Development and Validation of Bioanalytical Methods and Their Use in Pharmacy - Mayur S. Ingle, Shraddha K. Khatri, Dr. Balaji N. Thakare, Dr. Kailash Biyani - IJSAT Volume 16, Issue 2, April-June 2025. DOI 10.71097/IJSAT.v16.i2.3683
DOI https://doi.org/10.71097/IJSAT.v16.i2.3683
Short DOI https://doi.org/g9f2g5
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