Introduction.- Understanding Bioanalysis Regulations.- Logistical and Operational Practice in the Regulated Bioanalysis Laboratory.- Regulated Bioanalysis: Documentation and Reports.- Historical Aspects and Key Concepts Related to its Use.- Fundamentals of LC-MS/MS for Regulated Bioanalysis.- Liquid Chromatography-Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory.- Development and maintenance of critical reagents for ligand binding assays to support regulatory-compliant bioanalysis.- Ligand Binding Assays in the Regulated Bioanalytical Laboratory.
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