Bioanalytical Methods: Technological Platforms and Method Validation

In this chapter, we describe the importance of bioanalytical methods to drug development. These assays, measuring the active drug and metabolites, provide critical information on the exposure of the drug that is used to correlate with safety and efficacy data to demonstrate the appropriate selection of the dosage strength and frequency. Technologies discussed include those supporting small molecule drugs (chromatographic assays (LC-MS/MS)), biologics (immunoassays), and gene therapies (polymerase chain reaction assays (PCR)). This chapter reviews the predominant technologies and critical features in their use to provide reliable data, the characteristics of the assays that must be demonstrated during validation, and case studies highlighting many of these aspects.