1. E18 genomic sampling and management of genomic data Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Data Collection -- standardsGenomics -- standardsSpecimen Handling -- standardsConfidentialityGenetic TestingGenotyping TechniquesInformation Management -- standardsInformed ConsentInternational CooperationPrivacyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. 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.
