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. Selection of the experimental designs 4. Experimental work Execution of trials Minimising the influence of uncontrolled factors Using replicated experiments Using dummy variables 5. Determining responses Responses measured in a robustness test Corrected response results 6.
The definition for robustness/ruggedness applied is "The robustness/ruggedness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication …
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