Package: disprofas 0.2.0

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'))

Peer review:

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:

3.70 score 2 scripts 745 downloads 12 exports 29 dependencies

Last updated 5 months agofrom:26a8e1f555. Checks:OK: 7. Indexed: yes.

TargetResultDate
Doc / VignettesOKOct 11 2024
R-4.5-winOKOct 11 2024
R-4.5-linuxOKOct 11 2024
R-4.4-winOKOct 11 2024
R-4.4-macOKOct 11 2024
R-4.3-winOKOct 11 2024
R-4.3-macOKOct 11 2024

Exports:bootstrap_f2check_point_locationf1f2gep_by_neraget_hotellingsget_sim_limget_T2_oneget_T2_twomimcrmztiaplot_mztia

Dependencies:bootclicolorspacefansifarverggplot2gluegtableisobandlabelinglatticelifecyclemagrittrMASSMatrixmgcvmunsellnlmepillarpkgconfigR6RColorBrewerrlangscalestibbleutf8vctrsviridisLitewithr

Readme and manuals

Help Manual

Help pageTopics
Bootstrap f2bootstrap_f2
Check point locationcheck_point_location
Dissolution data of a reference and a test batchdip1
Dissolution data of one reference batch and five test batchesdip2
Dissolution data of two different capsule formulationsdip3
Dissolution data of two different formulationsdip4
Fluid weights of drink cansdip5
Dissolution data of a reference and a test batchdip6
Parameter estimates of Weibull fit to individual dissolution profilesdip7
Parameter estimates of Weibull fit to individual dissolution profilesdip8
Dissimilarity factor f1 for dissolution dataf1
Similarity factor f2 for dissolution dataf2
Get points on confidence region bounds by Newton-Raphson searchgep_by_nera
Hotelling's statistics (for two independent (small) samples)get_hotellings
Similarity limitget_sim_lim
Hotelling's statistics (for one (small) sample)get_T2_one
Hotelling's statistics (for two independent (small) samples)get_T2_two
Model-independent multivariate confidence region (MIMCR) proceduremimcr
Martinez & Zhao Tolerance Interval Approachmztia
Graphical representation of the of MZTIA estimationplot_mztia
Plot of the bootstrap f2 simulationplot.bootstrap_f2
Plot of the mztia simulationplot.plot_mztia
Print a summary of the bootstrap f2 simulationprint.bootstrap_f2
Print a summary of MIMCR estimationprint.mimcr
Print a summary of MZTIA estimationprint.mztia
Print a plot of MZTIA estimationprint.plot_mztia
Summary of the bootstrap f2 simulationsummary.bootstrap_f2
Summary of MIMCR estimationsummary.mimcr
Summary of MZTIA estimationsummary.mztia