Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: statistical analysis 172203002

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.] ]

Marsman FR, Akkermans AM, Hendriksen CFM, de Jong WH

19 p in English 1993

RIVM Rapport 172203002

Toon Nederlands

English 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.

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_{( 1993-11-30 )}