Package: disprofas 0.2.1.9000

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.

Authors:Pius Dahinden [aut, cre], Tillotts Pharma AG [cph, fnd]

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disprofas.pdf |disprofas.html✨
disprofas/json (API)
NEWS

# Install 'disprofas' in R:
install.packages('disprofas', repos = c('https://piusdahinden.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/piusdahinden/disprofas/issues

Datasets:
  • dip1 - Dissolution data of a reference and a test batch
  • dip2 - Dissolution data of one reference batch and five test batches
  • dip3 - Dissolution data of two different capsule formulations
  • dip4 - Dissolution data of two different formulations
  • dip5 - Fluid weights of drink cans
  • dip6 - Dissolution data of a reference and a test batch
  • dip7 - Parameter estimates of Weibull fit to individual dissolution profiles
  • dip8 - Parameter estimates of Weibull fit to individual dissolution profiles

On CRAN:

Conda:

3.74 score 2 scripts 685 downloads 11 exports 29 dependencies

Last updated 8 days agofrom:429d6f149a. Checks:9 OK. Indexed: yes.

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Doc / VignettesOKMar 23 2025
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R-4.4-winOKMar 23 2025
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R-4.4-linuxOKMar 23 2025
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Exports:bootstrap_f2check_point_locationf1f2gep_by_neraget_sim_limget_T2_oneget_T2_twomimcrmztiaplot_mztia

Dependencies:bootclicolorspacefansifarverggplot2gluegtableisobandlabelinglatticelifecyclemagrittrMASSMatrixmgcvmunsellnlmepillarpkgconfigR6RColorBrewerrlangscalestibbleutf8vctrsviridisLitewithr