Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 90, Issue -, Pages 22-28Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2017.08.008
Keywords
ICH M7; Expert review; Purge; Mutagenic impurity; Purge Ratio; Mirabilis
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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. (C) 2017 Elsevier Inc. All rights reserved.
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