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.
