title: Sample size calculation for the Power Model for dose proportionality studies.
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.
authors.affiliation: Biostatistics and Statistical Reporting, Novartis Pharmaceuticals, Florham Park, NJ 07932, USA. venkat.sethuraman@novartis.com
authors.forename: Venkat S
authors.initials: VS
authors.lastname: Sethuraman
authors.forename: Sergei
authors.initials: S
authors.lastname: Leonov
authors.forename: Lisa
authors.initials: L
authors.lastname: Squassante
authors.forename: Toni R
authors.initials: TR
authors.lastname: Mitchell
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hale
mesh_terms: 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