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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.
| Version: | 0.2.0 |
| Depends: | R (≥ 4.0) |
| Imports: | boot, ggplot2, rlang, lifecycle |
| Suggests: | testthat, T2EQ |
| Published: | 2024-06-10 |
| DOI: | 10.32614/CRAN.package.disprofas |
| Author: | Pius Dahinden [aut, cre], Tillotts Pharma AG [cph, fnd] |
| Maintainer: | Pius Dahinden <pius.dahinden at tillotts.com> |
| BugReports: | https://github.com/piusdahinden/disprofas/issues |
| License: | GPL-2 | GPL-3 [expanded from: GPL (≥ 2)] |
| URL: | https://github.com/piusdahinden/disprofas |
| NeedsCompilation: | no |
| Language: | en-GB |
| Materials: | README NEWS |
| CRAN checks: | disprofas results |
| Reference manual: | disprofas.pdf |
| Package source: | disprofas_0.2.0.tar.gz |
| Windows binaries: | r-devel: disprofas_0.2.0.zip, r-release: disprofas_0.2.0.zip, r-oldrel: disprofas_0.2.0.zip |
| macOS binaries: | r-release (arm64): disprofas_0.2.0.tgz, r-oldrel (arm64): disprofas_0.2.0.tgz, r-release (x86_64): disprofas_0.2.0.tgz, r-oldrel (x86_64): disprofas_0.2.0.tgz |
| Old sources: | disprofas archive |
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These binaries (installable software) and packages are in development.
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