Document Detail


A Bayesian approach to bioequivalence for the 2 x 2 changeover design.
MedLine Citation:
PMID:  7018605     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
M R Selwyn; A P Dempster; N R Hall
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  Biometrics     Volume:  37     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1981 Mar 
Date Detail:
Created Date:  1981-09-15     Completed Date:  1981-09-15     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  11-21     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Bayes Theorem*
Clinical Trials as Topic
Drug Combinations
Humans
Models, Biological*
Probability*
Therapeutic Equivalency*
Chemical
Reg. No./Substance:
0/Drug Combinations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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