개정된 생물학적 동등성 시험 기준에 대한 통계적 고찰

Abstract

On the new medical system separating the prescription and dispensing of the drug,the qualication of pharmacist in substitution of prescribed medicine was restricted, ex-cept bioequivalence-certied drugs. Also, Korean Fod and Drug Association(KFDA)revised the bioequivalence regulation on August, 2001. Among many changes fromold guideline, impressive one is the statistical consideration. Specially, to estimate andanalyze bioequivalence measures, AUC and Cmax , the log-transformed model is recom-mended and the equivalence interval is modied from 20 rule to [ln(0:8);ln(1:25)] one.This meaningful act is very hope-for because it is statistically reasonable and is agreedwith worldwide bioequivalence guideline, including USA, EU, Japan and Canada. In