TR 2022/253: The Impact of a QbD Approach: A Comparative Evaluation of Different Stoppers in a Simulated Leachables Data Model

This document summarizes a fit-for-purpose drug lyophilization simulation to demonstrate how extractables may translate to leachables.

The study presented here can provide a better understanding of what leachables could be present in a container closure system, which can enable a more accurate risk assessment regarding drug product compatibility.

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