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Developing Clinical Evidence for Regulatory and Coverage ...
Analytical validity is demonstrated by evidence that the assay results are accurate, repeatable and reproducible (precision), specific (minimal impact of bias-causing substances or conditions), and sensitive (limit of detection and limit of quantification if appropriate). References: CLSI.
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Modeling and Simulation (M&S) - MDIC
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www.uspnf.comeffects of formulation changes. Dissolution results may be considered highly variable if the relative standard deviation (RSD) is greater than 20% at time points of 10 minutes or less and greater than 10% RSD at later time points.1 However, most dissolution results exhibit less variability than this.