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A ruggedness test strategy for procedure related factors: experimental set-up and interpretation
Y V Heyden1, F Questier, D L Massart
1Vrije Universiteit Brussel, ChemoAC, Pharmaceutical Institute, Brussels, Belgium.
Abstract:
A strategy to perform ruggedness tests for mainly procedure related factors is described. The different steps in the set-up of the experiments and in the interpretation of the results are given. The described strategy is based on a number of case studies and allows a statistical interpretation of the significance of the effects. It was implemented in a software tool. This original strategy was completed with a number of minimal screening designs which reduce the number of experiments to perform, but in consequence only allow a limited or no statistical interpretation of the effects. Some of the minimal designs are expandable to designs with characteristics similar to those of the original strategy.