1. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Blood Specimen Collection -- methodsDrug Evaluation, Preclinical -- methodsPharmaceutical Preparations -- administration & dosageSample SizeToxicity Tests -- methodsToxicokineticsPharmacokineticsResearch DesignHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019 Subject(s): Compassionate Use Trials -- standardsCost-Benefit AnalysisDevice Approval -- standardsEquipment and Supplies -- classificationUncertaintyData CollectionReagent Kits, DiagnosticResearch DesignSample SizeHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
