Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1-2
pubmed:dateCreated
2000-12-12
pubmed:abstractText
Regulatory dossiers for new inhaled drug products generally contain in vitro data, which assess delivered dose and particle size distribution, together with clinical efficacy and safety data. Human lung deposition data may be generated using radionuclide imaging techniques or appropriate pharmacokinetic methods, and can act as a 'bridge' via which a seamless transition can be made between in vitro testing in the laboratory and efficacy/safety testing in the clinic. By enabling informed decisions to be made about the evaluation of new devices or formulations in man, lung deposition data permit a long and expensive clinical trials programme to be commenced with much greater certainty of a successful outcome. Human lung deposition data should be considered for supplementing the information required for regulatory dossiers.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0378-5173
pubmed:author
pubmed:issnType
Print
pubmed:day
4
pubmed:volume
208
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
49-60
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
Human lung deposition data: the bridge between in vitro and clinical evaluations for inhaled drug products?
pubmed:affiliation
Pharmaceutical Profiles Ltd, Mere Way, Ruddington Fields, Nottingham NG11 6JS, Ruddington, UK. snewman@pharmprofiles.co.uk
pubmed:publicationType
Journal Article, Review