title: A note on ethnic sensitivity studies.
abstract: In this article, we propose a similarity criterion for ethnic sensitivity studies in pharmacokinetic variables. We present how this criterion can be used in the context of different dose-exposure models and how sample size and power calculations can be done. Examples for the planning and analysis of ethnic sensitivity studies are provided.
authors.affiliation: Biostatistics and Statistical Reporting, Novartis Pharma AG, Basel, Switzerland. michaela.glasbrenner@novartis.com
authors.forename: Michaela
authors.initials: M
authors.lastname: Glasbrenner
authors.forename: Gerd
authors.initials: G
authors.lastname: Rosenkranz
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D005006:Ethnicity; D006801:Humans; D015233:Models, Statistical; D018579:Patient Selection; D010599:Pharmacokinetics; D018401:Sample Size