title: Youden test application in robustness assays during method validation.
abstract: Analytical method validation is a vital step following method development for ensuring reliable and accurate method performance. Among examined figures of merit, robustness/ruggedness study allows us to test performance characteristics of the analytical process when operating conditions are altered either deliberately or not. This study yields useful information, being a fundamental part of method validation. Since many experiments are required, this step is high demanding in time and consumables. In order to avoid the difficult task of performing too many experiments the Youden test which makes use of fractional factorial designs and has been proved to be a very effective approach. The main advantage of Youden test is the fact that it keeps the required time and effort to a minimum, since only a limited number of determinations have to be made, using combinations of the chosen investigated factors. Typical applications of this robustness test found in literature covering a wide variety of sample matrices are briefly discussed in this review.
authors: Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki, Thessaloniki 54124, Greece.
authors: Eftichia
authors: E
authors: Karageorgou
authors: Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki, Thessaloniki 54124, Greece. Electronic address: samanidu@chem.auth.gr.
authors: Victoria
authors: V
authors: Samanidou
mesh_terms: D000818:Animals; D001681:Biological Assay / Q000379:methods*; D004784:Environmental Monitoring; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations
keywords: Method validation; Robustness; Ruggedness; Youden test