Reporter-coded rechallenge as a selected documentation stratum: analysis repository for a bias-diagnostic FAERS study
收藏资源简介:
This repository contains reproducibility materials for the manuscript “Reporter-coded rechallenge as a selected documentation stratum: a bias-diagnostic analysis of hepatic reporting in oral targeted anticancer agents”. The repository includes analysis code, run-order documentation, source manifests, checksum files, the locked oral targeted anticancer drug dictionary, non-licensed aggregate outputs, diagnostic outputs, unit-reconciliation materials, and figure source data used to support the analyses reported in the manuscript. Raw FAERS quarterly ASCII files are not redistributed; they are publicly available from the U.S. Food and Drug Administration. Licensed MedDRA Standardised MedDRA Query preferred-term lists are not redistributed and require appropriate MedDRA access for local reproduction. The repository is intended to support transparent verification of the reported aggregate analyses. It does not contain patient-level clinical records, identifiable data, submission documents, or licensed MedDRA term lists.



