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Using Plackett Burman partial factorial designs for …

Using Plackett Burman partial factorial designs for method robustness testingBy D. A. DurdenCanadian Food Inspection AgencyCalgary Laboratory3650 36 St NWCalgary , ABReproducibility of a Method{Ruggedness{RobustnessRuggedness of a Method{ the degree of reproducibility of test results obtained by the analysis of the samesamples under a variety normaltest conditions USPR uggedness test conditionszDifferent{laboratories{analys ts{instruments{reagent lots{analysis days{elapsed assay times{assay temperatureszFactors are external to the methodzShould show a lack of influencezICH intermediate precision Robustness of a Method a measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability}}}}}}}}}}

Ruggedness of a Method {“the degree of reproducibility of test results obtained by the analysis of the same samples under a variety normal test conditions” USP

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