Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2000-7-19
pubmed:abstractText
Phase I trials to study the pharmacokinetic properties of a new drug generally involve a restricted number of healthy volunteers. Because of the nature of the group involved in such studies, the appropriate distributional assumptions are not always obvious. These model assumptions include the actual distribution but also the ways in which the dispersion of responses is allowed to vary over time and the fact that small concentrations of a substance are not easily detectable and hence are left censored. We propose that a reasonably wide class of generalized nonlinear models allowing for left censoring be considered now that this is feasible with current computer power and sophisticated statistical packages. These modelling strategies are applied to a Phase I study of the drug flosequinan and its metabolite. This drug was developed for the treatment of heart failure. Because the metabolite also exhibits an active pharmacologic effect, study of both the parent drug and the metabolite is of interest.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0006-341X
pubmed:author
pubmed:issnType
Print
pubmed:volume
56
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
81-8
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
Generalized nonlinear models for pharmacokinetic data.
pubmed:affiliation
Department of Medical Statistics, De Montfort University, Leicester, U.K. jlindsey@dmu.ac.uk
pubmed:publicationType
Journal Article, Clinical Trial, Clinical Trial, Phase I