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K-BEtestⓡ , 새로운 생물학적 동등성 시험 통계처리 프로그램의 개발
이영주(Young Joo Lee),최정호(Jung Ho Choi),송세흠(Sae Heum Song),서철환(Chul Hwan Seo),김동섭(Dong Sup Kim),박인숙(In Sook Park),최기환(Ki Hwan Choi),나한광(Han Kwang Na),정석재(Suk Jae Chung),이민화(Min Hwa Lee),심창구(Chang Koo Shi 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.4
N/A A computer program for personal computers, K-BEtest^ⓡ, was developed to analyze bioequivalence data in accordance with Korean Guidelines for Bioequivalence Test (KGBT). This program is user-friendly, interactive, Hangul-compatible and supports 2×2 cross-over design as well as 2×2 Latin square design with various significance levels. This program is able to calculate AUC, C_(max) and T_(max) parameters from the blood drug concentration-time profile of individual subjects and evaluate the parameters statistically for the bioequivalence by ±20% rule, the F-test, the Non-centrality test and 90% confidence intervals. All procedures are supported with graphic interface, interactive menu and outputs in Korean. In this paper, two experimental data sets were analyzed by the program and detailed process was demonstrated. The K-BEtest^ⓡ program appears to be very effective for analyzing bioequivalence data and can be widely used with convenience and accuracy.