Package implements the EDNEtest for equivalence according to Hoffelder et al. (2015) <DOI:10.1080/10543406.2014.920344>. "EDNE" abbreviates "Euclidean Distance between the Nonstandardized Expected values". The EDNEtest for equivalence is a multivariate twosample equivalence test. Distance measure of the test is the Euclidean distance. The test is an asymptotically valid test for the family of distributions fulfilling the assumptions of the multivariate central limit theorem (see Hoffelder et al.,2015). The function EDNE.EQ() implements the EDNEtest for equivalence according to Hoffelder et al. (2015). The function EDNE.EQ.dissolution.profiles() implements a variant of the EDNEtest for equivalence analyses of dissolution profiles (see SuarezSharp et al.,2020 <DOI:10.1208/s12248020004589>). EDNE.EQ.dissolution.profiles() checks whether the quadratic mean of the differences of the expected values of both dissolution profile populations is statistically significantly smaller than 10 [\% of label claim]. The current regulatory standard approach for equivalence analyses of dissolution profiles is the similarity factor f2. The statistical hypotheses underlying EDNE.EQ.dissolution.profiles() coincide with the hypotheses for f2 (see Hoffelder et al.,2015, SuarezSharp et al., 2020).
Package details 


Author  Thomas Hoffelder 
Maintainer  Thomas Hoffelder <thomas.hoffelder@boehringeringelheim.com> 
License  GPL3 
Version  1.0 
Package repository  View on CRAN 
Installation 
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