Pediatric Qualification Package for UGT1A1 Ontogeny

In this repository the electronic package for qualification of UGT1A1 ontogeny using in vivo probe substances are stored, including

• Input files (qualification plan, report text modules and observed data)
• Qualification Report

For the Qualification of the UGT1A1 mediated elimination of compounds, the following probe substance was included:

• Raltegravir [1]

Necessary software to execute the qualification workflow (see http://setup.open-systems-pharmacology.org for download links and instructions):

• QualificationRunner
• Reporting-Engine
• Markdown-joiner

References

[1] Raltegravir-Model, Whole-body PBPK model of Raltegravir.