Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2004-3-19
pubmed:abstractText
The need for careful testing of new drugs in animal models before study in humans has been recognised by physicians since the First World War. Now, first human studies on new drugs are subject to detailed government guidelines, which in the European Union are presently being reinforced through the wide-ranging Clinical Trials Directive. However, despite their long history and widespread application, these guidelines are empirical and have been formulated with a paucity of critical scientific evidence. Here, we review the principles and the available, albeit limited, evidence that support the design and conduct of preclinical studies in a way that permits effective and safe first-dose studies of potential new medicines in humans.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
1474-1776
pubmed:author
pubmed:issnType
Print
pubmed:volume
3
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
226-36
pubmed:dateRevised
2005-11-16
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
First dose of potential new medicines to humans: how animals help.
pubmed:affiliation
Medical Research Council Toxicology Unit, Hodgkin Building, University of Leicester, Lancaster Road, Leicester LE1 9HN, UK. pg29@le.ac.uk
pubmed:publicationType
Journal Article, Review