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So, You Want a New Analytical Method?  Past & Modern Day Considerations in Co-Lab Set-Up and Data Analysis
T. NELSEN (1) (1) Independent Consultant, Port Byron, IL, U.S.A..

The busy technical people in AACCI are often involved in developing new analytical methods or improving older, established methods. International chemical analytical organizations met at a workshop sponsored by IUPAC in 1987 and established Harmonization Guidelines which are still being used. These guidelines were set up for methods measuring constituent concentrations. The guidelines provide numbers required for laboratories, matrices, blind duplicates, and outlier testing plus they give formulae for calculating method performance parameters, most specifically Repeatability within labs and Reproducibility across labs. Modern methods developed by AACCI members often fit into the Guidelines but many are not exact fits.  The Guidelines do not address measuring near zero where Limits of Detection and Limits of Quantitation are estimated.  Physical tests often do not conform well to the Guidelines. In our modern electronic age, method development sometimes cannot be separated from instrument development. Technical Committees work with the developers to ensure the new methods are evaluated correctly. The role of the statistician is not to judge whether a method is good enough, but rather to ensure that the performance parameters are calculated correctly.  Potential users of the method should be able to compare methods based on accuracy and precision plus other criteria such as portability, costs and time required.

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