Linked Life Data

16959792

Source:http://linkedlifedata.com/resource/pubmed/id/16959792

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2006-9-8
pubmed:abstractText
The availability of biopharmaceuticals has been increasing over the past decade and as their patents expire, the emergence of biosimilar agents approaches. The primary issue of concern for the safety of these agents is the potential for immunogenicity. Both product- and host-related factors have documented impact on the immune response, but many factors are still unknown. Although in many cases the presence of antibodies may have little clinical consequence, the upsurge of pure red cell aplasia cases further increased concerns about potential clinical consequences of extensive use of biopharmaceuticals and biosimilars. Available laboratory measurement methods are insufficient to predict biological and clinical properties of biopharmaceuticals, or even to compare their bioequivalence. Comparison of results from different studies is complicated by the variability of assay measurements, presentation of data and lack of standardization.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
0931-0509
pubmed:author
pubmed:issnType
Print
pubmed:volume
21 Suppl 5
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
v9-12
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed:year
2006
pubmed:articleTitle
Immunogenicity of biopharmaceuticals.
pubmed:affiliation
Service de Néphrologie, Hôpitaux de Brabois, CHU de Nancy, 54500 Vandoeuvre les Nancy, France. m.kessler@chu-nancy.fr
pubmed:publicationType
Journal Article, Review