Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: statistical analysis
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Series / Report no.
Open Access
Type
Report
Language
en
Date
1993-11-30
Research Projects
Organizational Units
Journal Issue
Title
Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: statistical analysis
Translated Title
[Evaluatie en validatie van een een-punts-verdunning werkzaamheidstest gebaseerd op de serologie van difterie toxoid bevattende vaccins: statistische analyse.]
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Abstract
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.<br>
Description
Publisher
Rijksinstituut voor Volksgezondheid en Milieu RIVM
Sponsors
VHI