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- Publisher:Elsevier
- Publication Date:Aug 2017
- Reference:Regulatory Toxicology and Pharmacology, Volume 90, November 2017, Pages 22-28
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- Publication Type:Paper
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A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies
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.