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A note on ethnic sensitivity studies
Michaela Glasbrenner1, Gerd Rosenkranz
1Biostatistics and Statistical Reporting, Novartis Pharma AG, Basel, Switzerland. michaela.glasbrenner@novartis.com
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.
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