title: Reference datasets for bioequivalence trials in a two-group parallel design.
abstract: In order to help companies qualify and validate the software used to evaluate bioequivalence trials with two parallel treatment groups, this work aims to define datasets with known results. This paper puts a total 11 datasets into the public domain along with proposed consensus obtained via evaluations from six different software packages (R, SAS, WinNonlin, OpenOffice Calc, Kinetica, EquivTest). Insofar as possible, datasets were evaluated with and without the assumption of equal variances for the construction of a 90% confidence interval. Not all software packages provide functionality for the assumption of unequal variances (EquivTest, Kinetica), and not all packages can handle datasets with more than 1000 subjects per group (WinNonlin). Where results could be obtained across all packages, one showed questionable results when datasets contained unequal group sizes (Kinetica). A proposal is made for the results that should be used as validation targets.
authors.affiliation: Fuglsang Pharma, Hiort Lorenzens Vej 6c st. tv., 6100, Haderslev, Denmark, anfu@fuglsangpharma.com.
authors.forename: Anders
authors.initials: A
authors.lastname: Fuglsang
authors.forename: Helmut
authors.initials: H
authors.lastname: Schütz
authors.forename: Detlew
authors.initials: D
authors.lastname: Labes
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D066264:Datasets as Topic / Q000706:statistics & numerical data; D006801:Humans; D012984:Software; D013810:Therapeutic Equivalency; D054928:Validation Studies as Topic