생물학적 동등성 시험의 추가시험에 대한 통계적 고찰Statistical Considerations of the Add-On Test on Bioequivalence Trial
- Authors
- 박상규; 이재영; 정규진; 남봉현; 정윤노
- Issue Date
- Jan-2010
- Publisher
- 한국통계학회
- Keywords
- 생물학적 동등성; 생체이용률; 일관성; 추가시험; Add-on test; bioavailability; bioequivalence; consistency
- Citation
- Communications for Statistical Applications and Methods, v.17, no.1, pp 107 - 115
- Pages
- 9
- Journal Title
- Communications for Statistical Applications and Methods
- Volume
- 17
- Number
- 1
- Start Page
- 107
- End Page
- 115
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61037
- ISSN
- 2287-7843
- 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.
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.
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