Résumé
This proposed International Standard document provides a set of experimental designs and statistical analyses for evaluating aspects of the quality of a cell count-based cell viability analytical method. A set of quality indicators are derived from a cell concentration series experimental design a viability spike-in series experimental design to evaluate performance characteristics of the cell viability analytical method. These methods are primarily applicable to cell viability analytical methods that use differential cell count-based measurement processes. This method is suitable during cell viability method development, optimization, validation, evaluation and/or verification of cell viability measurement processes. This method is primarily applicable to eukaryotic cells. NOTE Several sector/application specific international and national standards for cell viability exist. Where applicable, consulting existing standards when operating within their scope can be helpful.
Informations générales
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État actuel: ProjetStade: Nouveau projet enregistré au programme de travail du TC/SC [20.00]
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Edition: 1
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Comité technique :ISO/TC 276/SC 1
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