A note on ethnic sensitivity studies.
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.
Glasbrenner
Michaela
M
Biostatistics and Statistical Reporting, Novartis Pharma AG, Basel, Switzerland. michaela.glasbrenner@novartis.com
Rosenkranz
Gerd
G
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