SAMPLE-SIZE DETERMINATION FOR BIOEQUIVALENCE ASSESSMENT USING A MULTIPLICATIVE MODEL

被引：62

作者：

HAUSCHKE, D

STEINIJANS, VW

DILETTI, E

BURKE, M

机构：

[1] Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz

来源：

JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS | 1992年 / 20卷 / 05期

关键词：

BIOEQUIVALENCE; BIOEQUIVALENCE RANGE; MULTIPLICATIVE MODEL; POWER; SAMPLE SIZE;

D O I：

10.1007/BF01061471

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

In bioequivalence studies C(max) and AUC serve as the primary pharmacokinetic characteristics of rate and extent of absorption. Based on pharmacokinetic relationships and on empirical evidence, the distribution of these characteristics corresponds to a multiplicative model, which implies a logarithmic normal distribution in the case of a parametric analysis. Hence, consideration is given to exact and approximate formulas of sample sizes in the case of a multiplicative model.

引用

页码：557 / 561

页数：5

共 9 条

[1]

DILETTI E, 1991, INT J CLIN PHARM TH, V29, P1

[2]

HAUCK WW, 1992, INT J CLIN PHARM TH, V30, P181

[3] ESTIMATION OF DIRECT FORMULATION EFFECT UNDER LOG-NORMAL DISTRIBUTION IN BIOAVAILABILITY BIOEQUIVALENCE STUDIES [J].