| A Bayesian approach to bioequivalence for the 2 x 2 changeover design. | |
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MedLine Citation:
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PMID: 7018605 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Bioequivalence trials are carried out to compare two or more formulations of a drug containing the same active ingredient, in order to determine whether the different formulation give rise to comparable blood levels. We consider the 2 x 2 changeover experiment the compares two formulations, one of which is considered the standard. For a single univariate characteristic of the plasma concentration--time curve, a criterion for bioequivalence is proposed based on the posterior probability that the difference in formulation means is less than a specific percentage of the mean of the standard. The sensitivity of this posterior probability to alternative priors is investigated. Differences in carry-over effects can be incorporated within the Bayesian framework without restoring to the "all-or-nothing" approach implied by a preliminary test. The use of sequential experimentation is discussed. |
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Authors:
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M R Selwyn; A P Dempster; N R Hall |
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Publication Detail:
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Type: Clinical Trial; Controlled Clinical Trial; Journal Article |
Journal Detail:
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Title: Biometrics Volume: 37 ISSN: 0006-341X ISO Abbreviation: Biometrics Publication Date: 1981 Mar |
Date Detail:
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Created Date: 1981-09-15 Completed Date: 1981-09-15 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0370625 Medline TA: Biometrics Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 11-21 Citation Subset: IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Bayes Theorem* Clinical Trials as Topic Drug Combinations Humans Models, Biological* Probability* Therapeutic Equivalency* |
| Chemical | |
Reg. No./Substance:
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0/Drug Combinations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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