Linked Life Data

18805705

Source:http://linkedlifedata.com/resource/pubmed/id/18805705

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2009-1-19
pubmed:abstractText
Vaccines differ from other pharmaceutical products. The quality and safety of batches are regulated to high standards by national regulatory authorities. Various quality control and safety tests have been developed, including the abnormal toxicity test (ATT), which is described in the World Health Organization (WHO) guidelines and in each country's pharmacopoeia. However, the criteria for abnormal results are not well defined in these guidelines. In addition, the animal grade to be used in ATT, classified on the basis of microbial colonization, was not designated in either guideline. In this study, we report a new and improved method of performing ATT, including statistical, histopathological analysis and hematological findings. It is based on the observation that there are body weight changes characteristic to each vaccine, and such standardized changes can be used as references for evaluating test vaccines. In addition, histopathological data are useful for determining vaccine quality and safety. Combined with histopathological examination, the improved ATT will be of great use for evaluating the consistency, quality and safety of different batches of vaccine. The results of these analyses were similar using either 'clean' or specific pathogen-free guinea pigs.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
1095-8320
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
37
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
8-17
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
An improved abnormal toxicity test by using reference vaccine-specific body weight curves and histopathological data for monitoring vaccine quality and safety in Japan.
pubmed:affiliation
Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, 4-7-1 Gakuen, Mushashi-murayama City, Tokyo 208-0011, Japan.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Validation Studies