Source:http://linkedlifedata.com/resource/pubmed/id/18493756
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
8
|
| pubmed:dateCreated |
2008-6-19
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| pubmed:abstractText |
Fulfilling bioequivalence criteria with highly variable drugs is difficult. The aim of this study was to compare the importance of sample size, intrasubject variability, and the point estimate of test and reference formulations with regard to meeting bioequivalence (BE) criteria [maximum observed plasma concentration (C(max)) and area under the concentration-time curve (AUC)].
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
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| pubmed:chemical | |
| pubmed:status |
MEDLINE
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| pubmed:month |
Aug
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| pubmed:issn |
0031-6970
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| pubmed:author | |
| pubmed:issnType |
Print
|
| pubmed:volume |
64
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| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
783-93
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| pubmed:meshHeading |
pubmed-meshheading:18493756-Area Under Curve,
pubmed-meshheading:18493756-Clinical Trials, Phase I as Topic,
pubmed-meshheading:18493756-Confidence Intervals,
pubmed-meshheading:18493756-Humans,
pubmed-meshheading:18493756-Pharmaceutical Preparations,
pubmed-meshheading:18493756-Pharmacokinetics,
pubmed-meshheading:18493756-Randomized Controlled Trials as Topic,
pubmed-meshheading:18493756-Research Design,
pubmed-meshheading:18493756-Therapeutic Equivalency
|
| pubmed:year |
2008
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| pubmed:articleTitle |
The importance of sample size, log-mean ratios, and intrasubject variability in the acceptance criteria of 108 bioequivalence studies.
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| pubmed:affiliation |
Clinical Pharmacology Department, La Paz University Hospital, School of Medicine, Autonomous University of Madrid, Arzobispo Morcillo s/n, Madrid, Spain. elena.ramirez@uam.es
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| pubmed:publicationType |
Journal Article
|