생물학적 동등성 시험의 추가시험에 대한 통계적 고찰
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 박상규 | - |
dc.contributor.author | 이재영 | - |
dc.contributor.author | 정규진 | - |
dc.contributor.author | 남봉현 | - |
dc.contributor.author | 정윤노 | - |
dc.date.accessioned | 2023-03-02T05:40:17Z | - |
dc.date.available | 2023-03-02T05:40:17Z | - |
dc.date.issued | 2010-01 | - |
dc.identifier.issn | 2287-7843 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61037 | - |
dc.description.abstract | 제제간의 생물학적 동등성을 입증하는데 실패했을 때 추가시험을 허용하는 새로운 생물학적 동등성 시험기준이 2008년 7월부터 시행하게 되었다. 추가시험의 의미나 시험기준에서 제시하는 절차를 살펴보고 추가시험의 통계학적 의미를 고찰한다. 또한 사례를 통해 추가시험을 고려할 경우 어떤 점에 유의하여야 성공할 수 있을 것인가 논의한다. | - |
dc.description.abstract | The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 and some discussion from statistical point of view would be needed for a practical use. The statistical model of add-on test is introduced and its two stage testing procedures are discussed. Meaningful statistical points of the add-on test are delivered through an illustrated example. | - |
dc.format.extent | 9 | - |
dc.publisher | 한국통계학회 | - |
dc.title | 생물학적 동등성 시험의 추가시험에 대한 통계적 고찰 | - |
dc.title.alternative | Statistical Considerations of the Add-On Test on Bioequivalence Trial | - |
dc.type | Article | - |
dc.identifier.bibliographicCitation | Communications for Statistical Applications and Methods, v.17, no.1, pp 107 - 115 | - |
dc.identifier.kciid | ART001417266 | - |
dc.description.isOpenAccess | N | - |
dc.citation.endPage | 115 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 107 | - |
dc.citation.title | Communications for Statistical Applications and Methods | - |
dc.citation.volume | 17 | - |
dc.identifier.url | https://kiss.kstudy.com/Detail/Ar?key=2822967 | - |
dc.publisher.location | 대한민국 | - |
dc.subject.keywordAuthor | 생물학적 동등성 | - |
dc.subject.keywordAuthor | 생체이용률 | - |
dc.subject.keywordAuthor | 일관성 | - |
dc.subject.keywordAuthor | 추가시험 | - |
dc.subject.keywordAuthor | Add-on test | - |
dc.subject.keywordAuthor | bioavailability | - |
dc.subject.keywordAuthor | bioequivalence | - |
dc.subject.keywordAuthor | consistency | - |
dc.description.journalRegisteredClass | kci | - |
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