Sample size calculation for the Power Model for dose proportionality studies.
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.
Sethuraman
Venkat S
VS
Biostatistics and Statistical Reporting, Novartis Pharmaceuticals, Florham Park, NJ 07932, USA. venkat.sethuraman@novartis.com
Leonov
Sergei
S
Squassante
Lisa
L
Mitchell
Toni R
TR
Hale
Michael D
MD
D000704:Analysis of Variance; D019540:Area Under Curve; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015233:Models, Statistical; D010599:Pharmacokinetics; D012107:Research Design; D018401:Sample Size; D013810:Therapeutic Equivalency