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Assessment and Interpretation of Bioequivalence for Two Drug Formulations using Crossover Design
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  • Assessment and Interpretation of Bioequivalence for Two Drug Formulations using Crossover Design
  • Assessment and Interpretation of Bioequivalence for Two Drug Formulations using Crossover Design
저자명
Ko. Seoung-gon,Oh. Hyun-Sook
간행물명
한국통계학회 논문집
권/호정보
1999년|6권 2호|pp.601-610 (10 pages)
발행정보
한국통계학회
파일정보
정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Crossover design is officially except for special occasions recommended by KFDA and FDA for assessing Bioequivalence between two drugs one for reference and the other for innovator. Such design is regarded as a special case of latin square split-polt or repeated measurement design and its main difference with other designing methods is that each subject in an experiment is exposed two drugs in sequence. Therefore general statistical analysis is not suitable since the model for this experiment includes carryover effect in addition to period and sequence effect. in this paper analysis for crossover model with two drugs and its interpretation are mainly discussed and an example is given for illustration.