Bioanalytical Method Development

Bioanalytical Method Development contains 9 topic pages in Pharmaceutical Quality Assurance.

Bioanalytical Method Development encompasses the design, optimisation, and validation of analytical procedures used to quantify drugs and their metabolites within biological matrices such as plasma, urine, whole blood, tissue, and saliva. These procedures form the scientific foundation of pharmacokinetic, pharmacodynamic, toxicokinetic, and bioequivalence studies that are mandatory prerequisites for the regulatory approval of both new chemical entities and generic pharmaceutical products. This chapter traces the complete bioanalytical workflow, beginning with the regulatory framework governing bioanalysis, proceeding through compound characterisation, biological matrix selection, sample preparation, chromatographic and mass spectrometric method development, and culminating in full method validation, incurred sample reanalysis, pharmacokinetic data analysis, and bioequivalence assessment. A rigorous understanding of this workflow is essential for pharmaceutical scientists engaged in drug development, clinical pharmacology, and regulatory affairs.