Linked Life Data

15119019

Source:http://linkedlifedata.com/resource/pubmed/id/15119019

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
94
pubmed:dateCreated
2004-5-3
pubmed:abstractText
Bioequivalence of formulations must be established by proving that the differences between the formulations are within a specified interval according to Equation 1, the Interval Hypothesis. Explicit estimates of sample size determined from Equation 8 and listed in Table 1 are qualitatively larger than those that would be determined from Equation 2, the Hypothesis of No Difference. Equation 8 was derived from the TOST procedure; other valid methods should yield comparable results. In any context, this discussion has illustrated that the failure to demonstrate a difference is not sufficient to demonstrate equivalence, and that a properly powered equivalence study of allergen formulations will generally demand many more than four study subjects.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0936-8671
pubmed:author
pubmed:issnType
Print
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
24-33
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2003
pubmed:articleTitle
Sample size considerations for establishing clinical bioequivalence of allergen formulations.
pubmed:affiliation
US Food and Drug Administration, Center for Biologics Evaluation, 1401 Rockville Pike (HFM-422), Rockville, MD 20852, USA.
pubmed:publicationType
Journal Article