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Industrial Case Studies Demonstrating Applicability of ICH M7 Control Options 3 and 4 for Nitrosamine Control Urquhart, Michael W.; Burns, Michael J.; Bernardoni, Frank; Clark, Hugh F.; Crochard, Jean-Philippe; De Benedetti, Alessandro; Dirat, Olivier; Fennell, Jared W.; Gall, Malcolm A. Y.; Galli, Marzia; Hildbrand, Stefan; Kallemeyn, Jeffrey M.; Kuhl, Nadine; Mack, Daniel J.; Moessner, Christian; Pascoe, David D.; Pozzoli, Alessandro; Risch, Philippe; Roberts, Alastair J.; Teasdale, Andrew; Thiel, Oliver R.; Tomlin, Paula; Whitehead, Andrew Share Save
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes Ponting, David J.; Czich, Andreas; Felter, Susan P.; Glowienke, Susanne; Harvey, James S.; Nudelman, Raphael; Schlingemann, Joerg; Simon, Stephanie; Smith, Graham F.; Teasdale, Andrew; Thomas, Robert Share Save
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Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide Gandhi, R. D.; Hickert, S.; Hoevelmann, Y.; Mee, C. D.; Schlingemann, J.; Adams, A.; Blanazs, A.; Simon, S.; Elloway, J.; Rigger, L.; Teasdale, A.; Beaumont, C. V.; Wright, L.; Doherty, A. Share Save
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Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies Urquhart, Michael W.; Burns, Michael J.; Clark, Hugh F.; Crochard, Jean-Philippe; Dirat, Olivier; Hildbrand, Stefan; Moessner, Christian; Pascoe, David D.; Roberts, Alastair J.; Teasdale, Andrew; Thiel, Oliver R. Share Save
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Revisiting the Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals Burns, Michael J.; Ponting, David J.; Foster, Robert S.; Thornton, Benjamin P.; Romero, Naiffer E.; Smith, Graham F.; Ashworth, Ian W.; Teasdale, Andrew; Simon, Stephanie; Schlingemann, Joerg Share Save
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Establishing Best Practice for the Application and Support of Solubility Purge Factors Burns, Michael J.; Andrews, Ian X.; Baumann, Jens-Christoph; Elliott, Eric L.; Fennell, Jared W.; Kallemeyn, Jeffrey M.; Lemaire, Sebastien; Murphy, Natasha S.; Palacio, Magali; Raw, Steven A.; Roberts, Alastair J.; Rocha, Nayrton Flavio Moura; Schils, Didier; Oestrich, Rolf Schulte; Shannon-Little, Andrew L.; Stevenson, Neil; Talavera, Pere; Teasdale, Andrew; Urquhart, Michael W.; Waechter, Fernanda Share Save
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Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines Popkin, Matthew E.; Goese, Markus; Wilkinson, Diane; Finnie, Stuart; Flanagan, Talia; Campa, Cristiana; Clinch, Alexandra; Teasdale, Andrew; Lennard, Andrew; Cook, Graham; Mohan, Ganapathy; Osborne, Matthew D. Share Save
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ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database Torres, Susana; Boetzel, Ruth; Gatimu, Enid; Gomes, Diego Zulkiewicz; King, Fiona; Kocks, Grace; Jones, Richard; Day, Christopher; Lewen, Nancy; Harris, Laurence; Teasdale, Andrew Share Save
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Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment Borths, Christopher J.; Argentine, Mark D.; Donaubauer, John; Elliott, Eric L.; Evans, Jared; Kramer, Timothy Talbot; Lee, Heewon; Parsons, Rodney; Roberts, Jeffrey C.; Sluggett, Gregory W.; Teasdale, Andrew; Urquhart, Michael; Wang, Ke; Zhuang, Ping Share Save
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