A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies

    loading  Checking for direct PDF access through Ovid

Abstract

The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This approach can reduce the burden of analytical testing without compromising patient safety, provided a scientifically rigorous approach is taken which is backed up by sufficient theoretical and/or analytical data. This paper introduces a consortium-led initiative and offers a proposal on the supporting evidence that could be presented in regulatory submissions.

Related Topics

    loading  Loading Related Articles