Linked Life Data

8749240

Source:http://linkedlifedata.com/resource/pubmed/id/8749240

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1996-9-18
pubmed:abstractText
Early-phase clinical trials with any new chemical entity have three main objectives: to establish that the drug is effective in the target disease and patient population; to assess tolerability and safety; and to select the optimum dose or doses for further evaluation. Clinical trials in migraine and other headache disorders pose additional problems because of the lack of specific objective diagnostic tests and the reliance on patient assessments of symptom relief. For these reasons particular care must be taken in selection of patients, design of the trials, choice of end-points and statistical analytical methodology. A wide range of doses must be evaluated to ensure that the dose-response curves for both efficacy and safety/tolerability are fully defined. Successful early-phase trials should then allow the optimum dose or doses of the drug to be identified for further evaluation in large-scale outpatient studies.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
0333-1024
pubmed:author
pubmed:issnType
Print
pubmed:volume
15 Suppl 15
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
10-3
pubmed:dateRevised
2008-2-11
pubmed:meshHeading
pubmed:year
1995
pubmed:articleTitle
Early-phase clinical trials in migraine: efficacy, safety and dose-finding.
pubmed:affiliation
Glaxo Research and Development Ltd, UK.
pubmed:publicationType
Journal Article, Review