| Literature DB >> 28822875 |
Chris Barber1, Vincent Antonucci2, Jens-Christoph Baumann3, Roland Brown4, Elizabeth Covey-Crump5, David Elder6, Eric Elliott7, Jared W Fennell8, Fabrice Gallou9, Nathan D Ide10, Guido Jordine9, Jeffrey M Kallemeyn10, Dirk Lauwers11, Adam R Looker12, Lucie E Lovelle9, Mark McLaughlin2, Robert Molzahn13, Martin Ott5, Didier Schils14, Rolf Schulte Oestrich3, Neil Stevenson15, Pere Talavera16, Andrew Teasdale17, Michael W Urquhart15, David L Varie8, Dennie Welch10.
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.Entities:
Keywords: Expert review; ICH M7; Mirabilis; Mutagenic impurity; Purge; Purge Ratio
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Year: 2017 PMID： 28822875 DOI： 10.1016/j.yrtph.2017.08.008
Source DB: PubMed Journal: Regul Toxicol Pharmacol ISSN： 0273-2300 Impact factor: 3.271