{ "_id": "6a1f0a48b401979e7341c4af", "Package": "PPQplan", "Type": "Package", "Title": "Process Performance Qualification (PPQ) Plans in Chemistry,\nManufacturing and Controls (CMC) Statistical Analysis", "Version": "1.1.0", "Authors@R": "c(\nperson(\"Yalin\", \"Zhu\", , \"yalin.zhu@merck.com\", role = c(\"aut\", \"cre\"),\ncomment = c(ORCID = \"0000-0003-3830-8660\")),\nperson(\"Merck & Co., Inc.\", role = c(\"cph\"))\n)", "Maintainer": "Yalin Zhu ", "Description": "Assessment for statistically-based PPQ sampling plan,\nincluding calculating the passing probability, optimizing the\nbaseline and high performance cutoff points, visualizing the\nPPQ plan and power dynamically. The analytical idea is based on\nthe simulation methods from the textbook Burdick, R. K.,\nLeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L.,\nVukovinsky, K., & Zhang, L. (2017). Statistical Methods for CMC\nApplications. In Statistical Applications for Chemistry,\nManufacturing and Controls (CMC) in the Pharmaceutical Industry\n(pp. 227-250). Springer, Cham.", "License": "MIT + file LICENSE", "VignetteBuilder": "knitr", "NeedsCompilation": "no", "RoxygenNote": "7.1.0", "Roxygen": "list(markdown = TRUE)", "Encoding": "UTF-8", "URL": "https://allenzhuaz.github.io/PPQplan/,\nhttps://github.com/allenzhuaz/PPQplan", "BugReports": "https://github.com/allenzhuaz/PPQplan/issues", "Language": "en-US", "Config/pak/sysreqs": "cmake make libicu-dev libuv1-dev libssl-dev", "Repository": "https://allenzhuaz.r-universe.dev", "Date/Publication": "2021-11-02 01:05:46 UTC", "RemoteUrl": "https://github.com/allenzhuaz/ppqplan", "RemoteRef": "HEAD", "RemoteSha": "c82a03aed629b4880e8c9ee17f49fe78b64883c5", "Packaged": { "Date": "2026-05-17 09:13:24 UTC", "User": "root" }, "Author": "Yalin Zhu [aut, cre] (ORCID: ),\nMerck & Co., Inc. 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"package": "R", "version": ">= 3.2.0", "role": "Depends" }, { "package": "ggplot2", "role": "Imports" }, { "package": "plotly", "role": "Imports" }, { "package": "knitr", "role": "Suggests" }, { "package": "rmarkdown", "role": "Suggests" }, { "package": "devtools", "role": "Suggests" } ], "_owner": "allenzhuaz", "_selfowned": true, "_usedby": 0, "_updates": [], "_tags": [], "_topics": [ "biostatistics", "pharmaceuticals", "sampling-methods" ], "_stars": 1, "_contributors": [ { "user": "allenzhuaz", "count": 39, "uuid": 5731610 } ], "_userbio": { "uuid": 5731610, "type": "user", "name": "Yalin Zhu", "description": "Statistician\r\n" }, "_downloads": { "count": 231, "source": "https://cranlogs.r-pkg.org/downloads/total/last-month/PPQplan" }, "_devurl": "https://github.com/allenzhuaz/ppqplan", "_pkgdown": "https://allenzhuaz.github.io/PPQplan/", "_searchresults": 13, "_rbuild": "4.6.0", "_assets": [ "extra/citation.cff", "extra/citation.html", "extra/citation.json", "extra/citation.txt", "extra/contents.json", "extra/NEWS.html", "extra/NEWS.txt", "extra/PPQplan.html", "extra/readme.html", "extra/readme.md", "manual.pdf" ], "_homeurl": "https://github.com/allenzhuaz/ppqplan", "_realowner": "allenzhuaz", "_cranurl": true, "_releases": [ { "version": "0.1.0", "date": "2018-06-15" }, { "version": "1.0.0", "date": "2019-09-03" }, { "version": "1.1.0", "date": "2020-10-08" } ], "_exports": [ "heatmap_ly", "k_factor", "pi_ctplot", "pi_occurve", "pi_pp", "pp", "PPQ_ctplot", "PPQ_ggplot", "PPQ_occurve", "PPQ_pp", "rl_pp", "ti_ctplot", "ti_occurve", "ti_pp" ], "_help": [ { "page": "heatmap_ly", "title": "A General Heatmap for Dynamically Assessing Power of the Sampling Plan Using a General Specification Limit.", "topics": [ "heatmap_ly" ] }, { "page": "k_factor", "title": "Estimating K-factors for Tolerance Intervals Based on Howe's Method", "topics": [ "k_factor" ] }, { "page": "pi_ctplot", "title": "Heatmap/Contour Plot for Assessing Power of the CQA PPQ Plan Using Prediction Interval.", "topics": [ "pi_ctplot" ] }, { "page": "pi_occurve", "title": "Operating Characteristic (OC) Curves for the CQA PPQ Plan using Prediction Interval.", "topics": [ "pi_occurve" ] }, { "page": "pi_pp", "title": "Probability of Passing PPQ Test using Prediction Interval", "topics": [ "pi_pp" ] }, { "page": "pp", "title": "Probability of Passing General Upper and/or Lower Specification Limit", "topics": [ "pp" ] }, { "page": "PPQ_ctplot", "title": "Heatmap/Contour Plot for Assessing Power of the CQA PPQ Plan Using General Multiplier.", "topics": [ "PPQ_ctplot" ] }, { "page": "PPQ_ggplot", "title": "Heatmap/Contour Plot for Dynamically Assessing Power of the CQA PPQ Plan Using General Multiplier.", "topics": [ "PPQ_ggplot" ] }, { "page": "PPQ_occurve", "title": "Operating Characteristic (OC) Curves for the CQA PPQ Plan Using General Multiplier.", "topics": [ "PPQ_occurve" ] }, { "page": "PPQ_pp", "title": "Probability of Passing PPQ Test Using General Multiplier", "topics": [ "PPQ_pp" ] }, { "page": "rl_pp", "title": "Probability of Passing Specification Test for a Release Batch", "topics": [ "rl_pp" ] }, { "page": "ti_ctplot", "title": "Heatmap/Contour Plot for Assessing Power of the PPQ Plan using Tolerance Interval.", "topics": [ "ti_ctplot" ] }, { "page": "ti_occurve", "title": "Operating Characteristic (OC) Curves for the PPQ Plan using Tolerance Interval.", "topics": [ "ti_occurve" ] }, { "page": "ti_pp", "title": "Probability of Passing PPQ Test using Tolerance Interval", "topics": [ "ti_pp" ] } ], "_readme": "https://github.com/allenzhuaz/ppqplan/raw/HEAD/README.md", "_rundeps": [ "askpass", "base64enc", "bslib", "cachem", "cli", "cpp11", "crosstalk", "curl", "data.table", "digest", "dplyr", "evaluate", "farver", "fastmap", "fontawesome", "fs", "generics", "ggplot2", "glue", "gtable", "highr", "htmltools", "htmlwidgets", "httr", "isoband", "jquerylib", "jsonlite", "knitr", "labeling", "later", "lazyeval", "lifecycle", "magrittr", "memoise", "mime", "openssl", "otel", "pillar", "pkgconfig", "plotly", "promises", "purrr", "R6", "rappdirs", "RColorBrewer", "Rcpp", "rlang", "rmarkdown", "S7", "sass", "scales", "stringi", "stringr", "sys", "tibble", "tidyr", "tidyselect", "tinytex", "utf8", "vctrs", "viridisLite", "withr", "xfun", "yaml" ], "_vignettes": [ { "source": "PPQplan-vignette.Rmd", "filename": "PPQplan-vignette.html", "title": "Introduction to Process Performance Qualification (PPQ) Sampling Plan R Package", "author": "Yalin Zhu (yalin.zhu@merck.com)", "engine": "knitr::rmarkdown", "headings": [ "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." ], "created": "2018-06-15 14:26:39", "modified": "2020-10-08 03:13:51", "commits": 6 }, { "source": "PPQnote.Rmd", "filename": "PPQnote.html", "title": "PPQ Power Assessment Theoretical Results", "author": "Yalin Zhu (yalin.zhu@merck.com)", "engine": "knitr::rmarkdown", "headings": [ "Preliminaries", "Specification test for one release batch", "Test for PPQ Batches" ], "created": "2019-08-28 05:39:08", "modified": "2020-10-08 01:50:55", "commits": 5 } ], "_score": 4.113943352306837, 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