On Determining a 1-Tailed Upper Limit for Future Sample HorRat Values

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Abstract:

Two formulas were developed for use in computing 1-tailed upper limits for future HorRat values obtained from the collaborative study of materials. One formula is applicable when a future sample HorRat value is computed based on a known concentration (e.g., C spike level and RSDR is the sample relative reproducibility standard deviation) and the other formula is applicable when the true concentration (C) is unknown and a future sample HorRat value is computed using the sample mean (e.g., , the collaborative study overall mean for an analyte). A Monte Carlo simulation procedure was developed using the Statistical Analysis System (SAS) software to assess the accuracy of the 2 developed formulas. Based on the degree of closeness between the simulated and calculated limits, the formulas for computing upper limits for future sample HorRat values will prove to be useful to Study Directors in determining worst case scenarios concerning a method's reproducibility precision relative to that predicted using the Horwitz equation. We also define the current empirical HorRat limits as 1-tailed 100p% upper limits to assess the statistical consequence, in a probability sense, of their application as an analytical methods screening tool.

Document Type: Research Article

Affiliations: Department of Health and Human Services, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Scientific Analysis and Support, Division of Mathematics, 5100 Paint Branch Pkwy, College Park, MD 20740-3835.

Publication date: November 1, 2006

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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