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Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 AAPS+J 2014 ; 16 (6): 1292-7 Nephropedia Template TP
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Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies #MMPMID25212768
Schütz H; Labes D; Fuglsang A
AAPS J 2014[Nov]; 16 (6): 1292-7 PMID25212768show ga
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.Electronic supplementary material: The online version of this article (doi:10.1208/s12248-014-9661-0) contains supplementary material, which is available to authorized users.