본문 바로가기
216.73.217.86
216.73.217.86
SCOPUS
3 × 3 라틴 방격법 모델에 따른 생물학적 동등성 시험의 통계 해석 : 온단세트론 제제에 대한 적용 예
Statatistical Analysis of Three Sequence-Three Periods Bioequivalence Study : Application to Bioequivalence Test of Ondansetron Formulations
이영주 , 이명걸 , 정석재 , 이민화 , 심창구 ( Young Joo Lee , Myung Gull Lee , Suk Jae Chung , Min Hwa Lee , Chang Koo Shim )
약제학회지 28권 1호 35-42(8pages)
UCI I410-ECN-0102-2008-510-000811471

A 3×3 Latin square crossover study for the bioequivalence of three ondansetron formulations was conducted. Test products were Vominon^ⓡ 8 ㎎ and Vominon^ⓡ ㎎ tablets and reference product was Zofran^ⓡ tablet. Twenty one healthy Korean male subjects received each formulation at the ondansetron dose of 8 ㎎ and plasma concentrations of ondansetron were monitored by HPLC for over a period of 12 hr after the oral administration. Statistical procedure for bioequivalence evaluation of AUC {e.g., analysis of variance (ANOVA), multiple comparison and confidence intervals} was carried out. There were no significant differences in AUC among the formulations. The confidence intervals for the AUC of Vominon^ⓡ 8 ㎎ and Vominon^ⓡ 4 ㎎ were between -0.24 and 15.54% and between -2.41 and 13.36% respectively, within a range that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence. These statistical procedure could be standardized and generally applicable for the assessment of bioequivalence for multiple (more than two) formulations.

[자료제공 : 네이버학술정보]
×