_            _    _        _         _
      /\ \         /\ \ /\ \     /\_\      / /\
      \_\ \       /  \ \\ \ \   / / /     / /  \
      /\__ \     / /\ \ \\ \ \_/ / /     / / /\ \__
     / /_ \ \   / / /\ \ \\ \___/ /     / / /\ \___\
    / / /\ \ \ / / /  \ \_\\ \ \_/      \ \ \ \/___/
   / / /  \/_// / /   / / / \ \ \        \ \ \
  / / /      / / /   / / /   \ \ \   _    \ \ \
 / / /      / / /___/ / /     \ \ \ /_/\__/ / /
/_/ /      / / /____\/ /       \ \_\\ \/___/ /
\_\/       \/_________/         \/_/ \_____\/
r-r4subprofile 0.1.0
Propagated dependencies: r-tibble@3.3.0 r-rlang@1.1.6 r-r4subcore@0.1.0 r-cli@3.6.5
Channel: guix-cran
Location: guix-cran/packages/r.scm (guix-cran packages r)
Home page: https://github.com/R4SUB/r4subprofile
Licenses: Expat
Build system: r
Synopsis: Regulatory Submission Profiles for Clinical Submission Readiness
Description:

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.

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