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16584285
Source:
http://linkedlifedata.com/resource/pubmed/id/16584285
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54
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Statements in which the resource exists as a subject.
Predicate
Object
rdf:type
pubmed:Citation
lifeskim:mentions
umls-concept:C0005552
,
umls-concept:C0008783
,
umls-concept:C0008902
,
umls-concept:C0013227
,
umls-concept:C0231448
,
umls-concept:C0456387
,
umls-concept:C1514468
pubmed:issue
4
pubmed:dateCreated
2006-4-4
pubmed:abstractText
The extension of biowaivers (drug product approval without a pharmacokinetic bioequivalence study) to drugs belonging to Class III of the Biopharmaceutics Classification System (BCS) is currently a subject of much discussion.
pubmed:language
eng
pubmed:journal
http://linkedlifedata.com/resource/pubmed/journal/7606849
pubmed:citationSubset
IM
pubmed:chemical
http://linkedlifedata.com/resource/pubmed/chemical/Cimetidine
,
http://linkedlifedata.com/resource/pubmed/chemical/Eudragit RSPO
,
http://linkedlifedata.com/resource/pubmed/chemical/Excipients
,
http://linkedlifedata.com/resource/pubmed/chemical/Polymethacrylic Acids
,
http://linkedlifedata.com/resource/pubmed/chemical/Tablets
pubmed:status
MEDLINE
pubmed:issn
0312-5963
pubmed:author
pubmed-author:AmidonGordon LGL
,
pubmed-author:DressmanJennifer BJB
,
pubmed-author:JantratidEkaratE
,
pubmed-author:PrakongpanSompolS
pubmed:issnType
Print
pubmed:volume
45
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
385-99
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:16584285-Adult
,
pubmed-meshheading:16584285-Biological Availability
,
pubmed-meshheading:16584285-Biopharmaceutics
,
pubmed-meshheading:16584285-Cimetidine
,
pubmed-meshheading:16584285-Drug Approval
,
pubmed-meshheading:16584285-Excipients
,
pubmed-meshheading:16584285-Humans
,
pubmed-meshheading:16584285-Intestinal Absorption
,
pubmed-meshheading:16584285-Male
,
pubmed-meshheading:16584285-Permeability
,
pubmed-meshheading:16584285-Polymethacrylic Acids
,
pubmed-meshheading:16584285-Solubility
,
pubmed-meshheading:16584285-Tablets
,
pubmed-meshheading:16584285-Therapeutic Equivalency
,
pubmed-meshheading:16584285-United States
,
pubmed-meshheading:16584285-United States Food and Drug Administration
pubmed:year
2006
pubmed:articleTitle
Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products: cimetidine.
pubmed:affiliation
Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.
pubmed:publicationType
Journal Article
,
Comparative Study
,
Randomized Controlled Trial
,
Research Support, Non-U.S. Gov't