Management of pharmaceutical ICH M7 (Q)SAR predictions - The impact of model updates.

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作者： Catrin,Hasselgren ^[1] ; Joel,Bercu ^[2] ; Alex,Cayley ^[3] ; Kevin,Cross ^[4] ; Susanne,Glowienke ^[5] ; Naomi,Kruhlak ^[6] ; Wolfgang,Muster ^[7] ; John,Nicolette ^[8] ; M Vijayaraj,Reddy ^[9] ; Roustem,Saiakhov ^[10] ; Krista,Dobo ^[11]

作者单位： Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. Electronic address: hasselgren.catrin@gene.com. ^[1] Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA. ^[2] Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, UK. ^[3] Leadscope, Inc. an Instem Company, 1393 Dublin Rd, Columbus, OH, 43215, USA. ^[4] Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH-4057, Basel, Switzerland. ^[5] FDA Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA. ^[6] Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland. ^[7] AbbVie Inc., Pre-clinical Safety, 1 North Waukegan Road, North Chicago, IL, USA. ^[8] Merck & Co., Inc., West Point, PA, 19486, USA. ^[9] Multicase Inc., 23811 Chagrin Boulevard, Suite 305, Beachwood, OH, 44122, USA. ^[10] Pfizer Worldwide Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA. ^[11]

关键词 Computational models ICH M7 Impurities Mutagenic Pharmaceuticals Q)SAR Version update