Transcription of Robustness/ruggedness tests in method validation
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Robustness/ruggedness tests in method validation
27/03/06. Guidance for Robustness/ruggedness tests in method validation Y. Vander Heydena, , J. Smeyers-Verbekea, Vandeginsteb and Massarta aVrije Universiteit Brussel, ChemoAC, Pharmaceutical Institute, Laarbeeklaan 103, 1090 Brussel, Belgium bUnilever Research Vlaardingen, Box 114, 3130 AC Vlaardingen, The Netherlands Content 1. Introduction Definitions Situating robustness in method development and validation Objectives of a robustness evaluation The steps in a robustness test 2. Selection of factors and levels Selection of the factors Mixture- related factors Quantitative factors Qualitative factors Selection of the factor levels Quantitative and mixture factors Asymmetric intervals for quantitative factors Qualitative factors 3.
performed at a late stage in the method validation since interlaboratory studies are performed in the final stage. Thus the robustness test was considered a part of method validation related to the precision (reproducibility) determination of the method [3,13-16].
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