未登录 In silico prediction of Ames mutagenicity for organosilicon compounds: Exploring and enhancing chemical space boundaries 基于计算机的有机硅化合物Ames致突变性预测:探索和增强化学空间边界 Schmitt, Barbara G.; Benfenati, Emilio; Foster, Robert S.; Kocks, Grace; Raitano, Giuseppa; Tennant, Rachael E.; Forlini, Carole; Gura, Eckart; Seidel, Shawn; Koraichi-Emeriau, Farah 分享 收藏
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Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop 亚硝胺Ames测试数据回顾与方法开发:美国FDA/HESI研讨会论文集 Atrakchi, Aisar; Puglisi, Raechel; Bercu, Joel; Cheung, Jennifer; Czich, Andreas; Froestchl, Roland; Davis-Bruno, Karen; Heflich, Robert H.; Kobets, Tetyana; McGovern, Timothy J.; Lynch, Anthony; Selby, Max; Schuler, Maik; Silveira, Gabriela De Oliveira; Vespa, Alisa; Whomsley, Rhys; Chen, Connie L. 分享 收藏
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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 分享 收藏
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug products 全面的可提取物和可浸出物敏化分析和基于风险的方法在肠胃外药物产品敏化评估中的实际应用 Parris, Patricia; Whelanb, Geraldine; Chilton, Martyn L.; Beaumonth, Claire; Burild, Anders; Bruen, Uma; Callis, Courtney; Graham, Jessica; Kovalovai, Natalia; Martin, Elizabeth A.; Masuda-Herrera, Melisa; Worsoek, Carsten; Alamil, Anissa; Bercuj, Joel; Doronm, Dvir; Dusenbury, Kristen; Fu, Qiang; Griffin, Troy; Hillegass, Jedd; Johann, Esther; Koenig, Agnes; Macho, Nina; Martirosyan, Alina; Oded, Kobi; Guarch, Constanca Porredon; Schmitz, Matthew; Stanard, Brad; Tien, Eric; Udovic, Erika; Xu, Haiyan; Cruz, Maureen T.; Nagao, Lee 分享 收藏
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes 药物产品中N-亚硝胺杂质的控制: 推进当前CPCA框架并支持稳健化合物特定可接受摄入量的推导 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 分享 收藏
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A developmental and reproductive toxicity adverse outcome pathway network to support safety assessments Myden, Alun; Cayley, Alex; Davies, Robert; Jones, Jade; Kane, Steven; Newman, Daniel; Payne, Martin P.; Ude, Victor C.; Vessey, Jonathan D.; White, Emma; Fowkes, Adrian 分享 收藏
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