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A Consortium-Driven Framework to Guide the Implementation of ICH M7 Option 4 Control Strategies

Chris Barber,Vincent Antonucci,Jens-Christoph Baumann,Roland Brown,Elizabeth Covey-Crump,David Elder,Eric Elliott,Jared W. Fennell,Fabrice Gallou,Nathan D. Ide,Guido Jordine,Jeffrey M. Kallemeyn,Dirk Lauwers,Adam R. Looker,Lucie E. Lovelle,Mark McLaughlin,Robert Molzahn, Martin Ott,Didier Schils,Rolf Schulte Oestrich,Neil Stevenson,Pere Talavera,Andrew Teasdale,Michael W. Urquhart,David L. Varie, Dennie Welch

Regulatory Toxicology and Pharmacology（2017）

引用 26|浏览23
关键词
ICH M7,Expert review,Purge,Mutagenic impurity,Purge Ratio,Mirabilis
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