불균형 자료의 3 × 3 교차설계법에서 생물학적 동등성 평가Assessing Bioequivalence in 3 × 3 Cross - over Design with Unbalanced Data
- Authors
- 임남규; 박상규
- Issue Date
- Sep-2001
- Publisher
- 한국통계학회
- Citation
- 응용통계연구, v.14, no.2, pp 345 - 356
- Pages
- 12
- Journal Title
- 응용통계연구
- Volume
- 14
- Number
- 2
- Start Page
- 345
- End Page
- 356
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/39754
- ISSN
- 1225-066x
2383-5818
- Abstract
- 동일한 유효성분을 가지면서 용량 혹은 형식 만이 다른 제제의 개발이 증가되고 이에 따른 두 제제 이상의 생물학적 동등성시험의 필요성이 제기되었다. 이에 이영주 등(1998)은 온단세트론 제제에 대한 생물학적 동등성시험에서 3×3 교차설계법을 적용하였다. 그러나 3×3 교차설계법에서 각 순서에 피험자의 수가 다르거나 실험중에 결락(dropout)되는 피험자가 발생하는 경우에는 일반적인 통계적 방법을 적용할 수 없었다. 본 연구에서는 이러한 경우에 제제효과의 추론에 대한 통계적 방법과 생물학적 동등성 시험 방법을 제안하고 모의실험을 통하여 생물학적 동등성평가의 정도를 측정하였다.
In recent years, the generic drug products which provide the same therapeutic effect with an innovator drug product have became very popular in pharmacokinetic area. Since assessing bioequivalence of a generic drug with the innovator is required prior to distribution in markets, bioequivalence studies in comparing several generic drugs simultaneously with the innovator is highly interested. In such circumstance, the Korean Drug Administration announces officially the partial acceptance regulation for the bioequivalence with the results from a 3×3 cross-over designs when the generic drugs which contain same active ingredients and are produced by a same company are compared with the innovator in a experiment. Lee et al.(1998), motivated from this new policy, try to assess bioequivalence of Ondensetron drugs using the 3×3 latin squares. But when 3×3 cross-over design have dropout or is unbalenced, standard statistical methods may not apply directly. for drug and period effects, we propose a method based on difference of the observations that eliminates the random subject effects.
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