1. Validate analytical robustness using experimental design
Assessing the robustness of the method naturally comes at the end of the development of the analytical procedure, or at the start of validation. The procedure, inspired by the work of Youden (1967), is based on the use of experimental design. This methodological approach makes it possible to evaluate the impact of k factors X i specific to the method on one or more responses Y (resolution, recovery...). A sequential approach is adopted.
1.1 Identifying factors and responses, defining the limits of experimental areas
The factors used in a robustness study are chosen according to the technical specificities of the analytical method under consideration. The experimenter must be able to adjust their levels during the...
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Validate analytical robustness using experimental design
Selection, construction and practical implementation of experimental design tests
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Bibliography
ISO 3534-3 Statistics - Vocabulary and symbols – Part 3: Experimental designs
ICH Q2 (R1): Validation of Analytical Procedures: Text and Methodology (2005)
W.J. Youden, Statistical Techniques for Collaborative Tests. Association of Official Analytical Chemists (AOAC), Washington, DC, USA (1967)
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