Linked Life Data

2625552

Source:http://linkedlifedata.com/resource/pubmed/id/2625552

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
1990-4-5
pubmed:abstractText
Since the DPT vaccine is broadly used for the prevention of diphtheria, tetanus and pertussis' its preparations should meet special quality requirements. The present study was aimed at evaluating the reproducibility of laboratory methods utilized to assess the protective activity and toxicity of the pertussis component as well as at examining the feasibility of expert estimations of product quality to enhance the validity of findings. The results of interlaboratory comparative examination of quality parameters of the tested preparations revealed that the routine laboratory quality control methods were not sufficiently standardized as their application in different laboratories did not always produce identical results. The WHO criteria to evaluate the toxicity of pertussis vaccines are far from perfect since vaccines with pronounced toxicity can only be distinguished from those with moderate to mild toxicity after the administration to tested mice of vaccines at a single infant dose of 0.5 ml. To enhance the reproducibility of methods employed in the laboratory, appropriate standard specimens of the preparation should be used serving as a measure of different quality parameters; all test conditions should be also standardized as far as possible. To enable objective quality evaluation of medical biological preparations, the degree of experiment reproducibility should be regularly verified in interlaboratory tests on an international scale as well as inside those countries which have several manufacturers of a given preparation. It appears expedient to set up an international system of expert evaluation of quality of biological preparations by appointing several regional and national centres which meet the requirements for expert laboratories.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0022-1732
pubmed:author
pubmed:issnType
Print
pubmed:volume
33
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
453-62
pubmed:dateRevised
2000-12-18
pubmed:meshHeading
pubmed:year
1989
pubmed:articleTitle
Expert examination of the immunogenic activity and toxicity of the pertussis component of adsorbed and non-adsorbed diphtheria-tetanus-pertussis vaccines. Results of interlaboratory investigations under the WHO project "Reactogenicity and Toxicity of DPT Vaccines".
pubmed:affiliation
L.A. Tarasevich State Research Institute for the Standardization and Control of Medical Biological Preparations, Moscow, USSR.
pubmed:publicationType
Journal Article