Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies
| Autor: | Anders Fuglsang, Helmut Schütz, Detlew Labes |
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| Rok vydání: | 2014 |
| Předmět: |
Models
Statistical Computer science business.industry Biological Availability Datasets as Topic Pharmaceutical Science Bioequivalence Residual computer.software_genre Confidence interval Software Statistics Outlier Confidence Intervals Range (statistics) Computer Simulation Point estimation Data mining business computer Research Article |
| Zdroj: | The AAPS Journal. 16:1292-1297 |
| ISSN: | 1550-7416 |
| DOI: | 10.1208/s12248-014-9661-0 |
| Popis: | It is difficult to validate statistical software used to assess bioequivalence since very few datasets with known results are in the public domain, and the few that are published are of moderate size and balanced. The purpose of this paper is therefore to introduce reference datasets of varying complexity in terms of dataset size and characteristics (balance, range, outlier presence, residual error distribution) for 2-treatment, 2-period, 2-sequence bioequivalence studies and to report their point estimates and 90% confidence intervals which companies can use to validate their installations. The results for these datasets were calculated using the commercial packages EquivTest, Kinetica, SAS and WinNonlin, and the non-commercial package R. The results of three of these packages mostly agree, but imbalance between sequences seems to provoke questionable results with one package, which illustrates well the need for proper software validation. |
| Databáze: | OpenAIRE |
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