Cross-Regulator Renal/Hepatic Dose-Adjustment Divergence Atlas: data and reproducibility bundle
收藏资源简介:
Data, frozen inputs, figures and validation artefacts underlying an exposure-weighted atlas of where the US FDA label and the UK Summary of Product Characteristics diverge on renal and hepatic dose-adjustment guidance, for 399 single-ingredient drugs dispensed at high volume in both countries. No regulator is treated as ground truth; the measured quantity is the inter-regulator disagreement itself, weighted by dispensing volume (US Medicare Part D, UK NHS Prescription Cost Analysis). All source material is open and redistributable (openFDA Drug Labeling; electronic Medicines Compendium; Medicare Part D; NHS PCA). Includes the frozen drug panel and coding rubric (with an RFC-3161 trusted timestamp and an OpenTimestamps Bitcoin anchor as a pre-analysis freeze proof), the per-drug atlas (399 drugs), the per-cell FDA/UK codes and verdicts (1,995 cells), the silence typology, the three main figures, and the blinded external second-coder validation. See README.md for the full contents and data dictionary. The bundle is provided as a single zip preserving the directory structure, alongside README.md and LICENSE.txt.



