title: On power and sample size calculation in ethnic sensitivity studies.
abstract: In ethnic sensitivity studies, it is of interest to know whether the same dose has the same effect over populations in different regions. Glasbrenner and Rosenkranz (2006) proposed a criterion for ethnic sensitivity studies in the context of different dose-exposure models. Their method is liberal in the sense that their sample size will not achieve the target power. We will show that the power function can be easily calculated by numeric integration, and the sample size can be determined by bisection.
authors.affiliation: Novartis Pharmaceuticals Corporation, Zhangjiang Hi-Tech Park, Pudong, Shanghai, China. weim.zhang@novartis.com
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Venkat
authors.initials: V
authors.lastname: Sethuraman
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D005006:Ethnicity; D006801:Humans; D015233:Models, Statistical; D018401:Sample Size