Chapter 1 Role of bioanalysis in pharmaceutical drug development

Bioanalysis is the quantitative determination of drugs and their metabolites in biological fluids. This technique is used very early in the drug development process to provide support to drug discovery programs on the metabolic fate and pharmacokinetics of chemicals in living cells and in animals. Its use continues throughout the preclinical and clinical drug development phases, into post-marketing support and may sometimes extend into clinical therapeutic drug monitoring. The role of bioanalysis in pharmaceutical drug development is discussed, with focus on the particular activities that are performed within each stage of the development process and on the variety of sample preparation matrices encountered. Recent developments and industry trends for rapid sample throughput and data generation are introduced, together with examples of how these high throughput needs are being met in bioanalysis.