Bioanalysis of biological matrix samples using liquid chromatography–tandem mass spectrometry detection

Abstract Analytical methods and specifications are critical for ensuring the quality of drug substances and drug products. Bioanalytical methods and related prestudy and in-study validations are critical components in biomedical research, drug discovery, and development at postadministration of drug products in nonclinical and clinical studies. Bioanalysis in pharmaceutical research is a specific area representing quantitative analysis of drug-related components (e.g., drugs and their metabolites, protein therapeutics and catabolites), biomarkers, and any other analytes of interest in biological matrices, such as plasma, serum, urine, and tissue. Bioanalysis utilizes many analytical platforms, measuring different types of targeted analytes and components, and answering a broad range of questions related to biomedical researches. This chapter will focus on the bioanalytical method development and its validation, as well as the regulations related to the LC-MS technology platform for the analysis of drugs, metabolites, proteins, and biomarkers in support of nonclinical and clinical studies.