SAMPLE-SIZE DETERMINATION FOR THE 2 ONE-SIDED TESTS PROCEDURE IN BIOEQUIVALENCE

被引：73

作者：

LIU, JP ^{[1
]}

CHOW, SC ^{[1
]}

机构：

[1] BRISTOL MYERS SQUIBB CO,BIOSTAT & DATA MANAGEMENT,PLAINSBORO,NJ 08536

来源：

JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS | 1992年 / 20卷 / 01期

关键词：

SAMPLE SIZE; POWER; BIOEQUIVALENCE;

D O I：

10.1007/BF01143188

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Approximate formulae of sample sizes for Schuirmann's two one-sided tests procedure are derived for bioequivalence studies with the 2 x 2 crossover design. These formulae are simple enough to be carried out with a pocket calculator.

引用

页码：101 / 104

页数：4

共 5 条

[1] A SPECIAL CASE OF BIVARIATE NON-CENTRAL T-DISTRIBUTION [J].

OWEN, DB .

BIOMETRIKA, 1965, 52 :437-&

[2] POWER OF THE 2 ONE-SIDED TESTS PROCEDURE IN BIOEQUIVALENCE [J].

PHILLIPS, KF .

JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1990, 18 (02) :137-144

[3] A COMPARISON OF THE 2 ONE-SIDED TESTS PROCEDURE AND THE POWER APPROACH FOR ASSESSING THE EQUIVALENCE OF AVERAGE BIOAVAILABILITY [J].

SCHUIRMANN, DJ .

JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1987, 15 (06) :657-680

[4]

SCHUIRMANN DJ, 1990, DRUG INF J, V24, P315

[5]

Westlake WJ, 1988, BIOPHARMACEUTICAL ST, P329

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