T2EQ (version 1.1)

T2EQ-package: Functions for Applying the $T^2$-Test for Equivalence

Description

Contains functions for applying the $T^2$-test for equivalence. The $T^2$-test for equivalence is a multivariate two-sample equivalence test. Distance measure of the test is the Mahalanobis distance. For multivariate normally distributed data the $T^2$-test for equivalence is exact and UMPI. The function T2EQ() implements the $T^2$-test for equivalence according to Wellek (2010). The function T2EQ.dissolution.profiles.hoffelder() implements a variant of the $T^2$-test for equivalence according to Hoffelder (2016) for the equivalence comparison of highly variable dissolution profiles.

Details

\Sexpr[results=rd,stage=build]{tools:::Rd_package_indices("#1")}T2EQ Index: This package was not yet installed at build time.

References

Wellek, S. (2010), Testing Statistical Hypotheses of Equivalence and Noninferiority. Second edition. Boca Raton: Chapman & Hall/CRC.

Hoffelder, T., Goessl, R., Wellek, S. (2015). Multivariate Equivalence Tests for Use in Pharmaceutical Development. Journal of Biopharmaceutical Statistics, 25:3, 417-437. URL: http://dx.doi.org/10.1080/10543406.2014.920344

Hoffelder, T. (2016). Highly Variable Dissolution Profiles: Comparison of $T^2$-Test for Equivalence and $f_2$ Based Methods. pharmind, 78:4, 587-592. URL: http://www.ecv.de/suse_item.php?suseId=Z|pi|8430

Tsong, Y., Hammerstrom, T., Sathe, P., Shah, V.P. (1996). Statistical Assessment of Mean Differences between two Dissolution Data Sets. Drug Information Journal, 30:4, 1105-1112. URL: http://dx.doi.org/10.1177/009286159603000427

EMA (2010). Guidance on the Investigation of Bioequivalence. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

Examples

## Not run: A recalculation of the example evaluation in Hoffelder et al. (2015) 
# can be done with the following code:## End(Not run)

data(ex_data_JoBS)
REF_JoBS <- cbind(ex_data_JoBS[ which(ex_data_JoBS$Group=='REF'), ]
            [c("Diss_15_min","Diss_20_min","Diss_25_min")])
TEST_JoBS <- cbind(ex_data_JoBS[ which(ex_data_JoBS$Group=='TEST'), ]
            [c("Diss_15_min","Diss_20_min","Diss_25_min")])
equivalence_margin_JoBS <- 0.74^2
test_T2EQ_JoBS <- T2EQ(X=REF_JoBS,Y=TEST_JoBS,eq_margin = equivalence_margin_JoBS)

## Not run: A recalculation of the results underlying Figure 1 in Hoffelder (2016) 
# can be done with the following code:## End(Not run)

data(ex_data_pharmind)
REF_pharmind <- cbind(ex_data_pharmind[ which(ex_data_pharmind$Group=='REF'), ]
                  [c("Diss_10_min","Diss_20_min","Diss_30_min")])
TEST_pharmind <- cbind(ex_data_pharmind[ which(ex_data_pharmind$Group=='TEST'), ]
                  [c("Diss_10_min","Diss_20_min","Diss_30_min")])
test_T2EQ.dissolution.profiles.hoffelder_pharmind <- 
      T2EQ.dissolution.profiles.hoffelder(X=REF_pharmind,Y=TEST_pharmind)