Show simple item record

dc.contributor.authorMarsman FR
dc.contributor.authorAkkermans AM
dc.contributor.authorHendriksen CFM
dc.contributor.authorde Jong WH
dc.date.accessioned2014-01-17T13:55:45
dc.date.issued1993-11-30
dc.identifier172203002
dc.description.abstractThis 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>
dc.description.sponsorshipVHI
dc.format.extent19 p
dc.language.isoen
dc.publisherRijksinstituut voor Volksgezondheid en Milieu RIVM
dc.relation.ispartofRIVM Rapport 172203002
dc.relation.urlhttp://www.rivm.nl/bibliotheek/rapporten/172203002.html
dc.subject02nl
dc.subjectdifterie toxoidnl
dc.subjectdpt-vaccinnl
dc.subjectvalidatienl
dc.subjectserodiagnostieknl
dc.subjectdiphtheria toxoiden
dc.subjectdpt-vaccineen
dc.subjectvalidationen
dc.subjectserodiagnosisen
dc.titleEvaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: statistical analysisen
dc.title.alternative[Evaluatie en validatie van een een-punts-verdunning werkzaamheidstest gebaseerd op de serologie van difterie toxoid bevattende vaccins: statistische analyse.]nl
dc.typeReport
dc.date.updated2014-01-17T12:58:03Z
html.description.abstractThis 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&apos;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.&lt;br&gt;


This item appears in the following Collection(s)

Show simple item record