1. Bioanalytical method validation Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Drug Evaluation, Preclinical -- standardsReproducibility of ResultsResearch Design -- standardsValidation Studies as TopicBiomarkersDocumentationDried Blood Spot Testing -- standardsInvestigational New Drug ApplicationQuality ControlReagent Kits, Diagnostic -- standardsSensitivity and SpecificitySpecimen Handling -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
