Hepatotox Package

Hepatotox Catalog

The catalog is a series of outputs for a Stage 1 Hepatotoxicity white paper considering a set of aggregate analyses and displays to rule out potential drug-induced liver injury (DILI). The catalog was generated using TERN and random.cdisc.data packages.

Safety Analyses White Paper

The analyses and displays in this catalog were based on the recommendations in a white paper developed by the PHUSE Safety Analytics working group. The white paper is titled:

"Recommendations for Analyses and Displays Associated with Hepatotoxicity with a Focus on Phase 2–4 Clinical Trials and Integrated Submission Documents. Stage 1: Initial Assessment and Screening for Potential of Hepatotoxicity."

View PDF

Shiny App Demo

The following is an output comparing maximum total bilirubin vs. maximum other liver enzymes (ALT, AST, or ALP). Interact with the Shiny App directly below:

Usage

Setup and pre-processing of synthetic data.

Code to produce the output.
The output generated by the given code.
An interactive application that can alternatively be used to produce and interact with the graph.

Interacting with Catalog R Code

The full source code of each article can be viewed by selecting the *Source Code* tab at the top of the page and copied using the *Copy* button.

License

This catalog as well as code examples are licensed under the Apache License, Version 2.0 - see the LICENSE file for details.

Contributing

We welcome contributions big and small to the Hepatotox toolkit.

Development

This website is built using Quarto and hosted on GitHub Pages.