[Tests for robustness of biomedical and pharmaceutical analytic methods].
In biomedical and pharmaceutical analysis, especially in the analyses executed in the pharmaceutical industry, the quality of the results obtained is strictly evaluated and controlled. Therefore, newly developed methods of analysis are subjected to a strict and vast method validation. One of the validation criteria studied is the determination of the robustness of the method. This is done by means of a robustness test. In this manuscript the different steps required to set up and interpret a robustness test are discussed and illustrated with a number of examples.
Vander Heyden
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Vrije Universiteit Brussel Laarbeeklaan 103-B 1090 Brussel.
D002623:Chemistry Techniques, Analytical / Q000379:methods / Q000592:standards*; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity