Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7
pubmed:dateCreated
1995-12-4
pubmed:abstractText
In the planning phase of a therapeutic equivalence trial, a range has to be specified that defines the parameter region within which the treatments to be compared are considered equal for practical purposes. It is current practice in equivalence assessment to fix some value for limiting the equivalence range and to test the corresponding null hypothesis in confirmatory analysis. This procedure is unsatisfactory, if, for example, the drug to be investigated is not only equivalent but turns out to be even superior to standard. In this situation it would be desirable to test not only for equivalence but also for superiority. The paper presents an alternative approach that allows for a flexible handling of the problem. If therapeutic equivalence can be established the method additionally allows, under maintenance of the multiple level, for testing all null hypotheses that correspond to acceptable equivalence ranges and even of superiority. Because of the special structure of the hypotheses no alpha-adjustment is needed for these additional confirmatory analyses.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
0946-1965
pubmed:author
pubmed:issnType
Print
pubmed:volume
33
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
388-90
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1995
pubmed:articleTitle
A confirmatory strategy for therapeutic equivalence trials.
pubmed:affiliation
Department of Biometry, Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany.
pubmed:publicationType
Journal Article