| pubmed-article:15119019 | rdf:type | pubmed:Citation | lld:pubmed |
| pubmed-article:15119019 | lifeskim:mentions | umls-concept:C0002092 | lld:lifeskim |
| pubmed-article:15119019 | lifeskim:mentions | umls-concept:C0242618 | lld:lifeskim |
| pubmed-article:15119019 | lifeskim:mentions | umls-concept:C0039789 | lld:lifeskim |
| pubmed-article:15119019 | lifeskim:mentions | umls-concept:C0524527 | lld:lifeskim |
| pubmed-article:15119019 | lifeskim:mentions | umls-concept:C0205210 | lld:lifeskim |
| pubmed-article:15119019 | pubmed:issue | 94 | lld:pubmed |
| pubmed-article:15119019 | pubmed:dateCreated | 2004-5-3 | lld:pubmed |
| pubmed-article:15119019 | 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. | lld:pubmed |
| pubmed-article:15119019 | pubmed:language | eng | lld:pubmed |
| pubmed-article:15119019 | pubmed:journal | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15119019 | pubmed:citationSubset | IM | lld:pubmed |
| pubmed-article:15119019 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15119019 | pubmed:status | MEDLINE | lld:pubmed |
| pubmed-article:15119019 | pubmed:issn | 0936-8671 | lld:pubmed |
| pubmed-article:15119019 | pubmed:author | pubmed-author:RabinRonald... | lld:pubmed |
| pubmed-article:15119019 | pubmed:author | pubmed-author:PastorRichard... | lld:pubmed |
| pubmed-article:15119019 | pubmed:author | pubmed-author:SlaterJay EJE | lld:pubmed |
| pubmed-article:15119019 | pubmed:author | pubmed-author:LachenbruchPe... | lld:pubmed |
| pubmed-article:15119019 | pubmed:issnType | Print | lld:pubmed |
| pubmed-article:15119019 | pubmed:owner | NLM | lld:pubmed |
| pubmed-article:15119019 | pubmed:authorsComplete | Y | lld:pubmed |
| pubmed-article:15119019 | pubmed:pagination | 24-33 | lld:pubmed |
| pubmed-article:15119019 | pubmed:dateRevised | 2007-11-15 | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:meshHeading | pubmed-meshheading:15119019... | lld:pubmed |
| pubmed-article:15119019 | pubmed:year | 2003 | lld:pubmed |
| pubmed-article:15119019 | pubmed:articleTitle | Sample size considerations for establishing clinical bioequivalence of allergen formulations. | lld:pubmed |
| pubmed-article:15119019 | pubmed:affiliation | US Food and Drug Administration, Center for Biologics Evaluation, 1401 Rockville Pike (HFM-422), Rockville, MD 20852, USA. | lld:pubmed |
| pubmed-article:15119019 | pubmed:publicationType | Journal Article | lld:pubmed |
