Package: EDNE.EQ 1.0

Thomas Hoffelder

EDNE.EQ: Implements the EDNE-Test for Equivalence

Package implements the EDNE-test for equivalence according to Hoffelder et al. (2015) <doi:10.1080/10543406.2014.920344>. "EDNE" abbreviates "Euclidean Distance between the Non-standardized Expected values". The EDNE-test for equivalence is a multivariate two-sample 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 EDNE-test for equivalence according to Hoffelder et al. (2015). The function EDNE.EQ.dissolution.profiles() implements a variant of the EDNE-test for equivalence analyses of dissolution profiles (see Suarez-Sharp et al.,2020 <doi:10.1208/s12248-020-00458-9>). 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, Suarez-Sharp et al., 2020).

Authors:Thomas Hoffelder

EDNE.EQ_1.0.tar.gz
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EDNE.EQ.pdf |EDNE.EQ.html✨
EDNE.EQ/json (API)

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Exports:EDNE.EQEDNE.EQ.dissolution.profiles

Dependencies:MASS