Analytical Method Development and Validation in Accordance to the Regulatory Guidelines

Abstract

Best practices and detailed requirements to perform LCMS bioanalysis for submission to regulatory agencies are defined in this chapter. The rationale for regulations is discussed, along with recommendations on achieving compliance. Novel drug candidates, new technology, and innovative processes continue to change LCMS bioanalysis. The evolution of global regulatory guidance is also shaping bioanalysis to test assays in a more consistent and thorough manner. Common procedures are now in place for validation and sample analysis of both large and small molecules, allowing consistent review of new drug applications. Influence from GMPs is seen in incurred sample reanalysis and associated out‐of‐specification investigations in bioanalysis. The nature of regulated bioanalysis is ever changing as new methodology and guidance challenges past practices.