Lovelle, Lucie, Gallou, Fabrice, Jordine, Guido and Mirabilis consortium, over 30 companies (2017) A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies. Regulatory Toxicology and Pharmacology, 90. pp. 22-28. ISSN 10960295

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.

Item Type:	Article
Keywords:	Expert review ICH M7 Mirabilis Mutagenic impurity Purge Purge Ratio
Date Deposited:	17 Oct 2017 00:45
Last Modified:	25 Jan 2019 00:45
URI:	https://oak.novartis.com/id/eprint/32274