In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey

Regulatory Toxicology and Pharmacology - Tập 62 - Trang 449-455 - 2012
Krista L. Dobo1, Nigel Greene1, Charlotta Fred2, Susanne Glowienke3, James S. Harvey4, Catrin Hasselgren5, Robert Jolly6, Michelle O. Kenyon1, Jennifer B. Munzner1, Wolfgang Muster7, Robin Neft8, M. Vijayaraj Reddy9, Angela T. White4, Sandy Weiner10
1Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA
2Safety Assessment, AstraZeneca R&D Södertälje, 151 85 Södertälje, Sweden
3Novartis Pharma AG, Werk Klybeck, Klybeckstrasse 141, CH-4057 Basel, Switzerland
4GlaxoSmithKline, Park Road, Ware, Herts SG12 0DP, UK
5Global Safety Assessment, AstraZeneca R&D, S-431 83 Mölndal, Sweden
6Eli Lilly and Company, Indianapolis, IN 46285, USA
7F. Hoffmann-La Roche Ltd., Pharma Research and Early Development, CH-4070 Basel, Switzerland
8Covance Laboratories Inc., 671 South Meridian Road, Greenfield, IN 46140, USA
9Merck Research Laboratories, West Point, PA, 19486, USA
10Johnson & Johnson Drug Safety Sciences, Route 202 South, Raritan, NJ 08869, USA

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Regulatory Toxicology and Pharmacology

Tập 62

449-455

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