로그변환 모델에 따른 생물학적 동등성 판정 연구

• 영문명: Analysis of Bioequivalence Study using a Log-transformed Model
• 발행기관: 대한약학회
• 저자명: 이영주(Young Joo Lee) 김윤균(Yoon Goon Kim) 이명걸(Myung Gull Lee) 정석재(Suk Jae Chung) 이민화(Min Hwa Lee) 심창구(Chang Koo Shim)
• 간행물 정보: 『약학회지』제44권 제4호 (2000년), 308~314쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2000.08.30

영문 초록

Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).

키워드

Bioequivalence log transformed model SAS aceclofenac.