Preparation of Compassionate Use Data for Quality Regulatory Submissions: Experience with Glucarpidase Development for Methotrexate Toxicity

Time

Wed, Jun 27 11:00AM
W 06

Title

Preparation of Compassionate Use Data for Quality Regulatory Submissions: Experience with Glucarpidase Development for Methotrexate Toxicity

Abstract Summary

We prepared a regulatory dossier based primarily on data from uncontrolled compassionate use trials of glucarpidase treatment for MTX toxicity conducted between 1993 and 2011. We describe how challenges in data entry, validation, standardization and statistical analysis were addressed.

Poster Presenter

Claire Daugherty
BTG International Inc.
United States

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