{"title":"Test design and results of a method performance characterization study for SPF and UVA-PF testing","authors":"Bertrand Colson, Jürgen Vollhardt, Curtis Cole, Ludger Kolbe, Paul Matts, Benoit Muller, Luciano Nogueira, Sergio Oliveira, Marc Pissavini, Florence Pouradier, Gerald Renner, Mathias Rohr, Eduardo Ruvolo, Caroline Tricaud, ALT-SPF Consortium, Steffen Uhlig","doi":"10.1111/ics.70019","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>This paper presents the experimental design, the statistical model, performance criteria and results of a method performance study conducted in order to characterize the performance of alternative methods for SPF and UVA-PF testing. The performance of alternative methods is characterized against the performance of the ISO 24444 and ISO 24443 methods.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>A factorial experimental design was implemented. For a given method, such a design allows good statistical reliability of precision estimates with as few as four participating laboratories. To cover the wide range of sunscreen products on the market, 32 sunscreens were tested. These 32 products were classified into eight product groups. The product groups differ in terms of SPF level, application viscosity and type of UV filters and matrix. In co-operation with a WG7 ISO ad hoc group performance criteria for the alternative methods were developed for reproducibility precision, between-laboratory variation, bias and the variation of bias across products and across product groups.</p>\n </section>\n \n <section>\n \n <h3> \n Results\n </h3>\n \n <p>Performance characteristics for the reference method along with reproducibility and repeatability limits are provided. The results for the participating alternative methods will be presented in separate articles, following this paper.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The precision of ISO 24444 and ISO 24443 was characterized for each of the eight product groups. The main sources of variation were identified for each of the two reference methods. Reproducibility and repeatability limits were derived and are provided.</p>\n </section>\n </div>","PeriodicalId":13936,"journal":{"name":"International Journal of Cosmetic Science","volume":"47 S1","pages":"2-24"},"PeriodicalIF":2.5000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ics.70019","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Cosmetic Science","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/ics.70019","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objective
This paper presents the experimental design, the statistical model, performance criteria and results of a method performance study conducted in order to characterize the performance of alternative methods for SPF and UVA-PF testing. The performance of alternative methods is characterized against the performance of the ISO 24444 and ISO 24443 methods.
Methods
A factorial experimental design was implemented. For a given method, such a design allows good statistical reliability of precision estimates with as few as four participating laboratories. To cover the wide range of sunscreen products on the market, 32 sunscreens were tested. These 32 products were classified into eight product groups. The product groups differ in terms of SPF level, application viscosity and type of UV filters and matrix. In co-operation with a WG7 ISO ad hoc group performance criteria for the alternative methods were developed for reproducibility precision, between-laboratory variation, bias and the variation of bias across products and across product groups.
Results
Performance characteristics for the reference method along with reproducibility and repeatability limits are provided. The results for the participating alternative methods will be presented in separate articles, following this paper.
Conclusions
The precision of ISO 24444 and ISO 24443 was characterized for each of the eight product groups. The main sources of variation were identified for each of the two reference methods. Reproducibility and repeatability limits were derived and are provided.
期刊介绍：
The Journal publishes original refereed papers, review papers and correspondence in the fields of cosmetic research. It is read by practising cosmetic scientists and dermatologists, as well as specialists in more diverse disciplines that are developing new products which contact the skin, hair, nails or mucous membranes.
The aim of the Journal is to present current scientific research, both pure and applied, in: cosmetics, toiletries, perfumery and allied fields. Areas that are of particular interest include: studies in skin physiology and interactions with cosmetic ingredients, innovation in claim substantiation methods (in silico, in vitro, ex vivo, in vivo), human and in vitro safety testing of cosmetic ingredients and products, physical chemistry and technology of emulsion and dispersed systems, theory and application of surfactants, new developments in olfactive research, aerosol technology and selected aspects of analytical chemistry.
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