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Statistical Interpretation of Add-on Study in Bioequivalence Trial
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| DC Field | Value | Language |
|---|---|---|
| dc.contributor.author | Park, Sang-Gue | - |
| dc.contributor.author | Jang, Junghoon | - |
| dc.date.accessioned | 2023-03-02T08:40:48Z | - |
| dc.date.available | 2023-03-02T08:40:48Z | - |
| dc.date.issued | 2008 | - |
| dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61041 | - |
| dc.description.abstract | Recently KFDA (2008) published the new regulations in bioequivalence trials. The important change of the newly amended regulations is to allow the add-on trial when the initial trial fails to prove the bioequivalence between two drugs. Some regulatory agencies (Canada, Japan and WHO) admit the add-on design, but some statistical problems like type I error rate inflation are still disputed. This paper provides the statistical model of the add-on design and tries to interpret the statistical properties of the current regulations about the add-on design by the simulation study. | - |
| dc.publisher | 한국통계학회 | - |
| dc.title | Statistical Interpretation of Add-on Study in Bioequivalence Trial | - |
| dc.type | Article | - |
| dc.identifier.bibliographicCitation | 한국통계학회 2008년 추계 학술논문발표회 | - |
| dc.description.isOpenAccess | N | - |
| dc.citation.title | 한국통계학회 2008년 추계 학술논문발표회 | - |
| dc.identifier.url | http://www.kss.or.kr/bbs/board.php?bo_table=scheduleview&idx=78&mode=last | - |
| dc.subject.keywordAuthor | Add-on design | - |
| dc.subject.keywordAuthor | Bioequivalence | - |
| dc.subject.keywordAuthor | Power | - |
| dc.subject.keywordAuthor | Type I error rate | - |
| dc.description.journalRegisteredClass | domestic | - |
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