References

Bell, B. 2006. “Issues with Open Source Statistical Software in Industry: Validation, Legal Issues, and Regulatory Requirements.” https://ww2.amstat.org/meetings/jsm/2006/onlineprogram/index.cfm?fuseaction=people_index&letter=B.
Bowsher, P. n.d. “Open-Source-in-New-Drug-Applications-NDAs-FDA.” https://github.com/philbowsher/Open-Source-in-New-Drug-Applications-NDAs-FDA.
Clark, Aaron, Robert Krajcik, Jeff Thompson, Lars Andersen, Andrew Borgman, Marly Gotti, Maya Gans, Aravind Reddy Kallem, and Fission Labs India Pvt Ltd. 2023. Riskassessment: A Web App Designed to Interface with the ‘Riskmetric‘ Package. https://github.com/pharmaR/riskassessment.
Drug Administration (FDA), U. S. Food &. 2015. “Statistical Software Clarifying Statement.” https://www.fda.gov/media/161196/download.
Hester, Jim. 2023. Covr: Test Coverage for Packages. https://covr.r-lib.org.
Kelkhoff, Doug, and Andrew McNeil. 2024. Covtracer: Tools for Contextualizing Tests. https://github.com/genentech/covtracer.
Knoph, Larsen, A. S. 2023. “Novo Nordisk’s Journey to an r Based FDA Submission.” https://www.youtube.com/watch?v=t33dS17QHuA.
Neitman, Martin, T. 2023. “Shifting to an Open-Source Backbone in Clinical Trials with Roche.” https://www.youtube.com/watch?v=nqJsLSLd39A.
“R Consortium Submissions Working Group.” 2021. https://rconsortium.github.io/submissions-wg/.
R Validation Hub, Doug Kelkhoff, Marly Gotti, Eli Miller, Kevin K, Yilong Zhang, Eric Milliman, and Juliane Manitz. 2024. Riskmetric: Risk Metrics to Evaluating r Packages. https://pharmar.github.io/riskmetric/.
RStudio Team. 2020. RStudio: Integrated Development Environment for r. Boston, MA: RStudio, PBC. http://www.rstudio.com/.
Schuette, P. 2018. “Using r in a Regulatory Environment: Some FDA Perspectives.” https://rinpharma.com/publication/rinpharma_7/.
Soukup, M. 2007. “Using r: Perspectives of a FDA Statistical RevieweR.” https://www.r-project.org/conferences/useR-2007/program/presentations/soukup.pdf; useR.
“Tidyverse, Tidymodels, r-Lib, and Gt r Packages: Regulatory Compliance and Validation Issues.” 2020. Posit / RStudio PBC. https://www.rstudio.com/assets/img/validation-tidy.pdf.
Wickham, Hadley, and Jenny Bryan. 2023. R Packages. O’Reilly Media, Incorporated.
Wickham, Hadley, Peter Danenberg, Gábor Csárdi, and Manuel Eugster. 2024. Roxygen2: In-Line Documentation for r. https://roxygen2.r-lib.org/.
Wickham, Hadley, Jay Hesselberth, and Maëlle Salmon. 2023. Pkgdown: Make Static HTML Documentation for a Package. https://pkgdown.r-lib.org.