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Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines 药品活性成分和药品制剂在药品中存在亚硝胺的质量风险管理工作流程 Dirat, Olivier; Urquhart, Michael W.; Akehurst, Heather; Burns, Michael J.; Dobo, Krista L.; Harvey, James; Kuhl, Nadine; Schlingemann, Joerg; Tomlin, Paula; Wetter, Christian 分享 收藏
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 分享 收藏
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N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da N-亚硝胺原料药相关杂质 (NDSRIs) -关于分子量> 200 Da的NDSRIs在致癌性效力分类方法类别1和2中增加子类别的建议 Bercu, Joel; Dirat, Olivier; Dobo, Krista; Jolly, Robert; Kenyon, Michelle; Harvey, James; Nudelman, Raphael; Smith, Graham; Trejo-Martin, Alejandra; Urquhart, Michael 分享 收藏
Current Approaches to Design Space Development and Regulatory Applications for Drug Products: Findings from the IQ Utilization of Design Space for Filings Working Group Survey Miesle, James E.; Osei-Yeboah, Frederick; Pauli-Bruns, Anette; Chen, Bei; Manceva, Slobodanka; Wade, Jonathan B.; Yin, Shawn; Desai, Divyakant; Dirat, Olivier; Bhugra, Chandan; Stauffer, Fanny 分享 收藏
Risk Assessment and Control of N-Nitrosamines in Antibody-Drug Conjugates: Current Industry Practices 抗体-药物结合物中N-亚硝胺的风险评估和控制: 当前行业惯例 Bulger, Paul G.; Jones, Michael T.; Ford, J. Gair; Schrier, Kate; Cole, Kevin P.; Bernardoni, Frank; Dirat, Olivier; Zhang, Qunying; Chahrour, Osama; Miller, Joy; Bonaga, Llorente; Parsons, Andrew T.; Yang, Lan 分享 收藏
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Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody-Drug Conjugates 用于产生抗体-药物偶联物的药物-接头中间体中N-亚硝胺的风险评估 Chahrour, Osama; Bulger, Paul G.; Dirat, Olivier; Schrier, Kate; Parsons, Andrew T.; Ford, J. Gair; Bernardoni, Frank; Hetrick, Evan M.; Bonaga, Llorente R.; Cole, Kevin P.; Miller, Joy; Zhang, Qunying; Jones, Michael T. 分享 收藏
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. 分享 收藏
Nitrite in Pharmaceutical Manufacturing Water: Development of an Ultra-Sensitive Analytical Method, Typical Data, and Discussion of Potential Nitrosamine Formation in Drug Substance and Drug Product from Water Suresh Kumar, A. B.; Dey, Debasis; Balaji, T. S.; Karthik, Haridoss; Sathishkumar, K.; Mcdaid, Paul; Fitzpatrick, Brian; Awasthi, Atul; Davies, Simon; Dirat, Olivier 分享 收藏
Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members Tymonko, Steven; Burke, Brenda J.; Crochard, Jean-Philippe; Dirat, Olivier; Fraunhoffer, Kenneth J.; Harrison, Cristian; Kramer, Timothy; Lee, Heewon; Liberman, Vlad; Sidhu, Kanwar P. S.; Smith, Randi; Strotman, Neil A.; Tandogan, Nil; Triman, Alan; Zhang, Haitao 分享 收藏
FDA/M-CERSI Co-Processed API Workshop Proceedings Schenck, Luke; Patel, Paresma; Sood, Ramesh; Bonaga, Llorente; Capella, Peter; Dirat, Olivier; Erdemir, Deniz; Ferguson, Steven; Gazziola, Cinzia; Gorka, Lindsey Saunders; Graham, Laurie; Ho, Raimundo; Hoag, Stephen; Hunde, Ephrem; Kline, Billie; Lee, Sau (Larry); Madurawe, Rapti; Marziano, Ivan; Merritt, Jeremy Miles; Page, Sharon; Polli, James; Ramanadham, Mahesh; Sapru, Mohan; Stevens, Ben; Watson, Tim; Zhang, Haitao 分享 收藏
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Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities 建立药品N-亚硝胺杂质可接受摄入量的实用和科学策略 Dobo, Krista L.; Kenyon, Michelle O.; Dirat, Olivier; Engel, Maria; Fleetwood, Andrew; Martin, Matthew; Mattano, Susan; Musso, Alyssa; McWilliams, James Christopher; Papanikolaou, Alexandros; Parris, Patricia; Whritenour, Jessica; Yu, Shu; Kalgutkar, Amit S. 分享 收藏
Development of an Intrinsically Safer Methanolysis/Aromatic Nitro Group Reduction for Step 1 and 2 of Talazoparib Tosylate Daniels, David S. B.; Crook, Robert; Dirat, Olivier; Fussell, Steven J.; Gymer, Adam; Hawksworth, Michael; Knight, Craig J.; Laity, Daniel; Mathew, Suju P.; Oke, Samantha, V; Peach, Philip; Prior, Samantha 分享 收藏
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