Bioanalysis

Bioanalysis is the quantitative measurement of xenobiotics, metabolites, or endogenous biomolecules in biological systems, typically to assess exposure, effect, or disease state. It underpins drug development and clinical pharmacology, toxicology, biomarker validation, environmental monitoring, food safety, and forensic investigations.

Common biological matrices include blood, plasma, serum, urine, tissue, cerebrospinal fluid, saliva, and other body fluids or solids. Proper collection, stabilization, and storage are essential to preserve analyte integrity.

Analytical methods used in bioanalysis include mass spectrometry–based techniques (notably LC-MS/MS and GC-MS), immunoassays (such as ELISA), nuclear magnetic resonance, and chromatographic separations such as HPLC. LC-MS/MS is widely favored for its sensitivity and specificity, while immunoassays offer rapid screening.

The typical workflow comprises sample preparation (protein precipitation, liquid-liquid extraction, or solid-phase extraction), separation, detection, calibration and quantification, and data analysis with reporting. Methods are validated to regulatory standards, with performance characteristics including accuracy, precision, linearity, limits of detection and quantification, recovery, and assessment of matrix effects.

Applications span pharmacokinetic studies and therapeutic drug monitoring; clinical toxicology; biomarker discovery and validation; environmental, occupational, and food-safety analyses; and forensic toxicology.

Challenges include complex and variable matrices, low-abundance analytes, stability concerns, and cross-lab reproducibility. Emerging trends emphasize high-resolution and quantitative MS, targeted and untargeted metabolomics, new sample-preparation approaches, and automation and data-processing advances.

This field integrates chemistry, biology, and informatics to provide decisions in medicine, safety, and research.