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… Show more
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