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.
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D002845:Chromatography / Q000379:methods*; D055808:Drug Discovery / Q000379:methods; D004345:Drug Industry / Q000379:methods; D007753:Laboratories; D020416:Outsourced Services / Q000379:methods
Contract Research Organization (CRO); Sponsor; bioanalysis; good laboratory practices (GLPs); new chemical entity (NCE)