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.VH
The immunogenicity of the diphtheria component of 73 commercial vaccines from five different manufac...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
This report describes the possible use of an in vitro culture system for the production of antibodie...
A single-dilution assay can be a valid procedure to demonstrate that a product exceeds the minimal r...
A single-dilution assay can be a valid procedure to demonstrate that a product exceeds the minimal r...
De op het RIVM geproduceerde batches DKTP worden op hun werkzaamheid gecontroleerd middels een door ...
Dit rapport bespreekt de analyse van verdunningsreeksen met maximum likelihood, met als toepassing h...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
AbstractVaccines are biological products made from living organisms. The natural complexity of biolo...
Immunoassays are used for routine potency assessment of several vaccines, in some cases having been ...
The primary concern of the vaccine industry is to produce vaccines with consistent high quality. To ...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
In the vaccine industry, multiple physicochemical, immunological, in vitro and in vivo analytical me...
Testen werden met elkaar vergele-ken, als mogelijke vervanger van de Vero Neutralisatietest (VN). Aa...
At present, the potency test of diphtheria toxoid is carried out on guinea pigs as experimental anim...
The immunogenicity of the diphtheria component of 73 commercial vaccines from five different manufac...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
This report describes the possible use of an in vitro culture system for the production of antibodie...
A single-dilution assay can be a valid procedure to demonstrate that a product exceeds the minimal r...
A single-dilution assay can be a valid procedure to demonstrate that a product exceeds the minimal r...
De op het RIVM geproduceerde batches DKTP worden op hun werkzaamheid gecontroleerd middels een door ...
Dit rapport bespreekt de analyse van verdunningsreeksen met maximum likelihood, met als toepassing h...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
AbstractVaccines are biological products made from living organisms. The natural complexity of biolo...
Immunoassays are used for routine potency assessment of several vaccines, in some cases having been ...
The primary concern of the vaccine industry is to produce vaccines with consistent high quality. To ...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
In the vaccine industry, multiple physicochemical, immunological, in vitro and in vivo analytical me...
Testen werden met elkaar vergele-ken, als mogelijke vervanger van de Vero Neutralisatietest (VN). Aa...
At present, the potency test of diphtheria toxoid is carried out on guinea pigs as experimental anim...
The immunogenicity of the diphtheria component of 73 commercial vaccines from five different manufac...
To check the potency of DPT vaccine, standard preparations of the components, namely Adsorbed Diphth...
This report describes the possible use of an in vitro culture system for the production of antibodie...