Linked Life Data

16143438

Source:http://linkedlifedata.com/resource/pubmed/id/16143438

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2005-10-11
pubmed:abstractText
Risk analysis in drug development aims to allow for clear decisions showing whether or not the benefit of an intervention outweighs the risk. One of the difficulties in doing this in a repeatable and clear way is the problem of comparing different adverse events, as seriousness is often subjective. Using drug-induced liver injury as our model, we show that clinical, laboratory, and histological manifestations of liver reactions can be ranked by experienced hepatologists and these rankings can be used to rank the consequences of drug-induced side effects as a continuum. This risk ranked information could be transformed to standardized scores (z score) and the risks displayed by standard techniques; adverse events can then be compared with effects from other drugs and possibly with the consequences due to untreated disease or natural occurrences. As a risk is a function of both the seriousness of the event and the probability of its occurrence, risk can therefore be displayed in terms of probability and hazard to further ease communication. We propose that risk management of drugs in development would be improved, especially in terms of risk communication, if the hazard were ranked by means of a common scale and displayed in graphic form against the likelihood of occurrence.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0273-2300
pubmed:author
pubmed:issnType
Print
pubmed:volume
43
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
134-40
pubmed:dateRevised
2009-11-19
pubmed:meshHeading
pubmed:year
2005
pubmed:articleTitle
Rating the severity of the medical consequences of drug-induced liver injury.
pubmed:affiliation
Pfizer Global Research and Development, Pfizer Inc., Sandwich, CT13 9NJ, England, UK.
pubmed:publicationType
Journal Article