Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2004-12-31
pubmed:abstractText
The objective of this study was to assess the relative usefulness of in vitro and canine data sets in the prediction of input rates of isosorbide-5-mononitrate (ISMN) from extended release (ER) products on a confidence interval basis. ISMN is a highly soluble compound with high permeability in the upper GI tract but not in the colon. Two ISMN ER tablet formulations were studied: Imdur and an osmotic pump. Differences between amount of drug absorbed versus time predicted from in vitro and canine data and results observed in humans were assessed using the estimated median value of the difference factor, f(1), and its associated 90% bootstrap confidence intervals. For both products, median f(1) values and their associated confidence intervals for the comparisons between in vitro and human profiles and between canine and human profiles were similar. Although the median difference between the human input profiles of the two ISMN ER products was equally well predicted by in vitro and canine data, the 90% confidence intervals for this difference were better predicted by the canine data.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
0928-0987
pubmed:author
pubmed:issnType
Print
pubmed:volume
24
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
115-22
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
2005
pubmed:articleTitle
In vitro versus canine data for predicting input profiles of isosorbide-5-mononitrate from oral extended release products on a confidence interval basis.
pubmed:affiliation
Laboratory of Biopharmaceutics and Pharmacokinetics, School of Pharmacy, University of Athens, Panepistimiopolis, 157 71 Zografou, Greece.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't