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Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: statistical analysis

[Evaluatie en validatie van een een-punts-verdunning werkzaamheidstest gebaseerd op de serologie van difterie toxoid bevattende vaccins: statistische analyse.]

Synopsis

This document presents the results of a validation study to the use of a single dilution assay in potency testing of the diphtheria component of DPT-polio vaccines. Based on historical data of multi-dilution assays on 27 consecutive batches a simulation study was performed to test the actual performance of a single dilution assay. Results were statistically analysed by means of the Student's test. From the study it is concluded that the single dilution assay in diphtheria potency testing of DPT-polio vaccines can be a valid procedure to demonstrate that products exceed the minimal requirements given for potency provided that consistency in production and testing has been proven.
 

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