title: On determining a 1-tailed upper limit for future sample HorRat values.
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 H [formula: see text] is computed based on a known concentration (e.g., C = spike level and RSD(R) 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 [formula: see text] is computed using the sample mean (e.g., y, 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.
authors.affiliation: DHHS, 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, USA. foster.mcclure@fda.hhs.gov
authors.forename: Foster D
authors.initials: FD
authors.lastname: McClure
authors.forename: Jung K
authors.initials: JK
authors.lastname: Lee
mesh_terms: D000465:Algorithms; D003627:Data Interpretation, Statistical; D015233:Models, Statistical; D009010:Monte Carlo Method; D015203:Reproducibility of Results; D012984:Software