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r4subprofile defines regulatory submission profiles for the R4SUB clinical submission readiness ecosystem.
Each profile bundles authority-specific pillar weights, decision thresholds, required indicators, and risk configuration for a given regulatory authority and submission type.
pak::pak("R4SUB/r4subprofile")| Authority | Country | Submission Types |
|---|---|---|
| FDA | United States | IND, NDA, BLA, ANDA, 505b2 |
| EMA | European Union | CTA, MAA, variation |
| PMDA | Japan | CTN, NDA_JP |
| Health_Canada | Canada | CTA_CA, NDS |
| TGA | Australia | CTN_AU, registration |
| MHRA | United Kingdom | CTA_UK, MAA_UK |
library(r4subprofile)
# Browse authorities
list_authorities()
list_submission_types("FDA")
# Create a profile
prof <- submission_profile("FDA", "NDA")
prof$pillar_weights
prof$required_indicators
# Extract configs compatible with r4subscore / r4subrisk
sci_cfg <- profile_sci_config(prof)
risk_cfg <- profile_risk_config(prof)
# Validate evidence against profile requirements
result <- validate_against_profile(evidence, prof)
result$is_compliant
result$missing_indicatorslibrary(r4subscore)
library(r4subprofile)
prof <- submission_profile("FDA", "NDA")
# Use profile weights for SCI computation
pillar_scores <- compute_pillar_scores(evidence, config = profile_sci_config(prof))
sci <- compute_sci(pillar_scores, config = profile_sci_config(prof))| Function | Purpose |
|---|---|
submission_profile() |
Create a regulatory submission profile |
list_authorities() |
List all supported regulatory authorities |
list_submission_types() |
List valid submission types for an authority |
profile_sci_config() |
Extract SCI configuration (r4subscore compatible) |
profile_risk_config() |
Extract risk configuration (r4subrisk compatible) |
profile_required_indicators() |
Get mandatory indicators for a profile |
validate_against_profile() |
Check evidence completeness vs profile |
profile_summary() |
Print formatted profile summary |
MIT
These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
Health stats visible at Monitor.