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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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| Publicado no: | J Diabetes Sci Technol |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
SAGE Publications
2019
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| Assuntos: | |
| Acesso em linha: | 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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