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Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models
BACKGROUND: The objective of this study was to estimate the combinations of total bias and total imprecision required for devices to meet the Food and Drug Administration (FDA) specifications using Monte Carlo simulation rather than collection and analysis of experimental data. METHODS: A model Gaus...
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| Veröffentlicht in: | J Diabetes Sci Technol |
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| Hauptverfasser: | , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
SAGE Publications
2019
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7576955/ https://ncbi.nlm.nih.gov/pubmed/31752535 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1932296819889639 |
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