A Review on Advances in Bioanalysis of Small Molecules and Biologics in Pharmaceutical Research
Keywords:
Bioanalysis, LC–MS/MS, Biologics, Pharmacokinetics, Biomarkers, Method Validation, MetabolomicsAbstract
Bioanalysis is an essential component of pharmaceutical and clinical research that involves the quantitative and qualitative determination of drugs, metabolites, biomarkers, peptides, proteins, and biologics in complex biological matrices. Recent advancements in analytical technologies have significantly improved the sensitivity, selectivity, accuracy, and throughput of bioanalytical methods used in drug development and therapeutic monitoring. This review highlights modern bioanalytical approaches employed for the analysis of small molecules and biologics, with special emphasis on chromatographic and mass spectrometric techniques such as HPLC, UPLC, LC–MS/MS, GC–MS, HRMS, capillary electrophoresis, and hybrid analytical platforms. The review discusses various biological matrices, method development strategies, validation parameters, and regulatory requirements according to FDA, EMA, and ICH guidelines. In addition, applications of bioanalysis in pharmacokinetics, pharmacodynamics, bioavailability, bioequivalence, biomarker discovery, metabolomics, and personalised medicine are comprehensively summarised. The analytical challenges associated with biologics, matrix effects, ion suppression, metabolite complexity, and ultra-trace level quantification are also discussed. Emerging hybrid analytical platforms and advanced bioanalytical technologies continue to improve analytical performance and support precision medicine approaches. Overall, modern bioanalysis plays a critical role in pharmaceutical development, clinical diagnostics, regulatory submissions, and therapeutic drug monitoring, thereby contributing significantly to advancements in healthcare and biomedical sciences.
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