Package: PPQplan 1.1.0

Yalin Zhu

PPQplan: Process Performance Qualification (PPQ) Plans in Chemistry, Manufacturing and Controls (CMC) Statistical Analysis

Assessment for statistically-based PPQ sampling plan, including calculating the passing probability, optimizing the baseline and high performance cutoff points, visualizing the PPQ plan and power dynamically. The analytical idea is based on the simulation methods from the textbook Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). Statistical Methods for CMC Applications. In Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (pp. 227-250). Springer, Cham.

Authors:Yalin Zhu [aut, cre], Merck & Co., Inc. [cph]

PPQplan_1.1.0.tar.gz
PPQplan_1.1.0.zip(r-4.7-any)PPQplan_1.1.0.zip(r-4.6-any)PPQplan_1.1.0.zip(r-4.5-any)
PPQplan_1.1.0.tgz(r-4.6-any)PPQplan_1.1.0.tgz(r-4.5-any)
PPQplan_1.1.0.tar.gz(r-4.7-any)PPQplan_1.1.0.tar.gz(r-4.6-any)
PPQplan_1.1.0.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
PPQplan/json (API)

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

Bug tracker:https://github.com/allenzhuaz/ppqplan/issues

Pkgdown/docs site:https://allenzhuaz.github.io

On CRAN:

Conda:

biostatisticspharmaceuticalssampling-methods

4.11 score 1 stars 13 scripts 298 downloads 14 exports 64 dependencies

Last updated from:c82a03aed6. Checks:9 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-develOK153
source / vignettesOK212
linux-releaseOK224
macos-releaseOK143
macos-oldrelOK227
windows-develOK100
windows-releaseOK86
windows-oldrelOK93
wasm-releaseOK135

Exports:heatmap_lyk_factorpi_ctplotpi_occurvepi_ppppPPQ_ctplotPPQ_ggplotPPQ_occurvePPQ_pprl_ppti_ctplotti_occurveti_pp

Dependencies:askpassbase64encbslibcachemclicpp11crosstalkcurldata.tabledigestdplyrevaluatefarverfastmapfontawesomefsgenericsggplot2gluegtablehighrhtmltoolshtmlwidgetshttrisobandjquerylibjsonliteknitrlabelinglaterlazyevallifecyclemagrittrmemoisemimeopensslotelpillarpkgconfigplotlypromisespurrrR6rappdirsRColorBrewerRcpprlangrmarkdownS7sassscalesstringistringrsystibbletidyrtidyselecttinytexutf8vctrsviridisLitewithrxfunyaml

Introduction to Process Performance Qualification (PPQ) Sampling Plan R Package
Functions | rl_pp: calculates probability of pass the specification test. | The following four functions are mainly for the sampling plan using statistical intervals with general multiplier | PPQ_pp: calculates the probability of passing some critical quality attributes (CQA) PPQ test using a general constant multiplier k. | PPQ_occurve: plots OC curves for specification test and PPQ plan, with the options of customizing CQA name, unit, number of batch, optimizing the plans, etc. | PPQ_ctplot: Heatmap (or Contour Plot) for PPQ assessment with parameter space. | PPQ_ggplot: Dynamic Heatmap (or Contour Plot) for PPQ assessment with parameter space. | The following three functions are used for sampling plan with prediction interval. | pi_pp: calculates the probability of passing the PPQ test using prediction interval with confidence level $100 \times 1-\alpha$. | pi_occurve: plots OC curves for specification test and PPQ plan, with the options of customizing CQA name, unit, number of batch, optimizing the plans, etc. | pi_ctplot: Heatmap (or Contour Plot) for PPQ assessment with parameter space. | The following three functions are used for sampling plan with tolerance interval. | ti_pp: calculates the probability of passing the PPQ test using one-sided or two-sided tolerance interval with confidence level $100 \times 1-\alpha$. | ti_occurve: plots OC curves for specification test and PPQ plan, with the options of customizing CQA name, unit, number of batch, optimizing the plans, etc. | ti_ctplot: Heatmap (or Contour Plot) for PPQ assessment with parameter space. | The package also provides two functions for a general sampling plan based on lower and/or upper specification limits. | pp: calculate the probability of passing general upper and/or lower specification limit. | heatmap_ly: plot a plain or dynamic heatmap (or contour plot) for a general sampling plan with specification limit.

Last update: 2020-10-08
Started: 2018-06-15

PPQ Power Assessment Theoretical Results
Preliminaries | Specification test for one release batch | Test for PPQ Batches

Last update: 2020-10-08
Started: 2019-08-28