Bioanalytical method transfer considerations of chromatographic-based assays

Bioanalysis is an important part of the modern drug development process. The business practice of outsourcing and transferring bioanalytical methods from laboratory to laboratory has increasingly become a crucial strategy for successful and efficient delivery of therapies to the market. This chapter discusses important considerations when transferring various types of chromatographic-based assays in today's pharmaceutical research and development environment. The era of the blockbuster drug therapy has disappeared over a decade ago. Generic erosion and higher drug development costs have caused pharmaceutical executives to rethink their R&D strategy to generate more value per dollar spent. The bioanalysis segment of the...