Sample size calculation for the Power Model for dose proportionality studies |
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Authors: | Sethuraman Venkat S Leonov Sergei Squassante Lisa Mitchell Toni R Hale Michael D |
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Institution: | Biostatistics and Statistical Reporting, Novartis Pharmaceuticals, Florham Park, NJ 07932, USA. venkat.sethuraman@novartis.com |
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Abstract: | There are several approaches to assess or demonstrate pharmacokinetic dose proportionality. One statistical method is the traditional ANOVA model, where dose proportionality is evaluated using the bioequivalence limits. A more informative method is the mixed effects Power Model, where dose proportionality is assessed using a decision rule for the estimated slope. Here we propose analytical derivations of sample sizes for various designs (including crossover, incomplete block and parallel group designs) to be analysed according to the Power Model. |
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Keywords: | power model dose proportionality sample size mixed effects model pharmacokinetic parameters |
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