Defines submission profiles per regulatory authority with authority-specific pillar weights, decision thresholds, indicator requirements, and risk configuration. Supports the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Therapeutic Goods Administration (TGA), and Medicines and Healthcare products Regulatory Agency (MHRA). Integrates with 'r4subscore' and 'r4subrisk' configuration systems.
| Version: | 0.1.0 |
| Depends: | R (≥ 4.2) |
| Imports: | cli, r4subcore, rlang, tibble |
| Suggests: | r4subscore, r4subrisk, testthat (≥ 3.0.0) |
| Published: | 2026-03-03 |
| DOI: | 10.32614/CRAN.package.r4subprofile (may not be active yet) |
| Author: | Pawan Rama Mali [aut, cre, cph] |
| Maintainer: | Pawan Rama Mali <prm at outlook.in> |
| BugReports: | https://github.com/R4SUB/r4subprofile/issues |
| License: | MIT + file LICENSE |
| URL: | https://github.com/R4SUB/r4subprofile |
| NeedsCompilation: | no |
| Materials: | README, NEWS |
| CRAN checks: | r4subprofile results |
| Reference manual: | r4subprofile.html , r4subprofile.pdf |
| Package source: | r4subprofile_0.1.0.tar.gz |
| Windows binaries: | r-devel: not available, r-release: not available, r-oldrel: not available |
| macOS binaries: | r-release (arm64): r4subprofile_0.1.0.tgz, r-oldrel (arm64): r4subprofile_0.1.0.tgz, r-release (x86_64): not available, r-oldrel (x86_64): not available |
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