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Sample size calculation for the Power Model for dose proportionality studies
Author(s) -
Sethuraman Venkat S.,
Leonov Sergei,
Squassante Lisa,
Mitchell Toni R.,
Hale Michael D.
Publication year - 2006
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.241
Subject(s) - bioequivalence , proportionality (law) , sample size determination , statistics , mathematics , crossover , econometrics , pharmacokinetics , computer science , medicine , pharmacology , artificial intelligence , law , political science
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. Copyright © 2006 John Wiley & Sons, Ltd.