Ligand Binding Assays in Drug Development

This chapter explains how immunoassays and other ligand-binding assays are applied during the different stages of drug identification and development in the pharmaceutical industry. The importance of the need to change paradigms to address the requirements of biologic development is stressed and the trends reflecting that need are described. Methods used in high-throughput screening to identify target compounds are reviewed. Lead optimization, the next phase, is described in detail and examples of how specific biomarkers benefited from thorough characterization during this phase are provided. The use of safety biomarkers and the subject of assay validation are described. The different stages of clinical studies are explained including how immunoassays are used to define and understand pharmacokinetics and pharmacodynamics. The implications for laboratories that provide the tests are explained, particularly the differences from routine diagnostic testing.