Portal de Periódicos da CAPES

A Simple Formula for Sample Size Calculation in Equivalence Studies

2003; Taylor & Francis; Volume: 13; Issue: 3 Linguagem: Inglês

10.1081/bip-120022772

1520-5711

Paul Zhang,

Optimal Experimental Design Methods

Bioequivalence and clinical equivalence can be claimed based on the two one-sided test approach or the confidence interval approach. Consequently the power function of the equivalence test can be derived from either noncentral t-distribution or central t-distribution. The sample size is then determined from the power function either by numerical method or closed formulas. In this paper, we propose a simple formula for sample size calculation based on central t-distribution. The proposed formula has better properties than those currently available and it can be easily applied in all equivalence studies.