Linked Life Data

18487871

Source:http://linkedlifedata.com/resource/pubmed/id/18487871

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2008-5-19
pubmed:abstractText
Biologics are a heterogeneous group of substances with unique characteristics that are clearly distinguishable from classical cytotoxic drugs. Current concepts for clinical oncology drug development are mostly based on experiences obtained with cytotoxic agents and therefore do not (or not properly) account for several aspects that are crucial when it comes to the use of new biologics. This can lead to extreme cases where new substances that clearly bear a potential of antitumor efficacy do not reach needed levels of significance in clinical trials or are never introduced to advanced stages of clinical testing at all. In order to increase the number of biologics that can be successfully led through all phases of clinical development the currently established standards will have to be reconsidered and modified in such a way that they meet the specific needs of the tested biologics. It is important to mention that such an agent-specific adjustment of clinical development paradigms does not mean that the currently demanded high standards of safety and quality will have to be lowered by any means. The most striking arguments for a new clinical development paradigm are exemplified for therapeutic tumor vaccines but also hold true for related biologics.
pubmed:language
ger
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
1423-0240
pubmed:author
pubmed:copyrightInfo
Copyright 2008 S. Karger AG, Basel.
pubmed:issnType
Electronic
pubmed:volume
31 Suppl 2
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
58-63
pubmed:meshHeading
pubmed:year
2008
pubmed:articleTitle
[Concepts for clinical testing of biological agents exemplified for vaccines].
pubmed:affiliation
Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands. c.m.britten@lumc.nl
pubmed:publicationType
Journal Article, English Abstract