disprofas: Non-Parametric Dissolution Profile Analysis
Similarity of dissolution profiles is assessed using the
similarity factor f2 according to the EMA guideline (European
Medicines Agency 2010) "On the investigation of bioequivalence".
Dissolution profiles are regarded as similar if the f2 value is
between 50 and 100. For the applicability of the similarity factor f2,
the variability between profiles needs to be within certain limits.
Often, this constraint is violated. One possibility in this situation
is to resample the measured profiles in order to obtain a bootstrap
estimate of f2 (Shah et al. (1998) <doi:10.1023/A:1011976615750>).
Other alternatives are the model-independent non-parametric
multivariate confidence region (MCR) procedure (Tsong et al. (1996)
<doi:10.1177/009286159603000427>) or the T2-test for equivalence
procedure (Hoffelder (2016)
<https://www.ecv.de/suse_item.php?suseId=Z|pi|8430>). Functions for
estimation of f1, f2, bootstrap f2, MCR / T2-test for equivalence
procedure are implemented.
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