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Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials
Authors:Fiona Sewell  Kathryn Chapman  Paul Baldrick  David Brewster  Alan Broadmeadow  Paul Brown  Leigh Ann Burns-Naas  Janet Clarke  Alex Constan  Jessica Couch  Oliver Czupalla  Andy Danks  Joseph DeGeorge  Lolke de Haan  Klaudia Hettinger  Marilyn Hill  Matthias Festag  Abby Jacobs  David Jacobson-Kram  Stephan Kopytek  Helga Lorenz  Sophia Gry Moesgaard  Emma Moore  Markku Pasanen  Rick Perry  Ian Ragan  Sally Robinson  Petra M. Schmitt  Brian Short  Beatriz Silva Lima  Diane Smith  Sue Sparrow  Yvette van Bekkum  David Jones
Affiliation:1. UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London NW1 2BE, UK;2. Covance Laboratories Ltd, Otley Road, Harrogate HG3 1PY, UK;3. Vertex Pharmaceuticals Inc., 50 Northern Avenue, Boston, MA 02139, USA;4. Huntingdon Life Sciences Ltd, Occold, Eye, Suffolk IP23 7PX, UK;5. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA;6. Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA;g Biogen Idec, Cambridge, MA 02142, USA;h Infinity Pharmaceuticals, 780 Memorial Drive, Cambridge, MA 02139, USA;i Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA;j Bayer Pharma AG, Müllerstrasse 170, 13353 Berlin, Germany;k Charles River Laboratories, Preclinical Services, Tranent, Edinburgh EH33 2NE, UK;l Merck, 770 Sumneytown Pike, Mailstop WP45-201, West Point, PA 19486, USA;m MedImmune, Granta Park, Cambridge CB21 6GH, UK;n Austrian Agency for Health and Food Safety, Traisengasse 5, 1200 Vienna, Austria;o Novartis Institutes for BioMedical Research (NIBR), Basel, Switzerland;p Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, CH – 4070 Basel, Switzerland;q Celgene, 86 Morris Avenue, Summit, NJ 07901, USA;r AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany;s Novo Nordisk A/S, Novo Nordisk Park, Maaloev, Denmark;t Huntingdon Life Sciences Ltd, Alconbury, Huntingdon, Cambridgeshire PE28 4HS, UK;u University of Eastern Finland, Faculty of Health Sciences, School of Pharmacy, Kuopio, Finland;v Pfizer Drug Safety Research and Development, 455 Eastern Point Rd., Groton, CT 06340, USA;w Board member, NC3Rs, Gibbs Building, 215 Euston Road, London NW1 2BE, UK;x AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK;y Paul-Ehrlich-Institute, Federal Agency for Vaccines and Biomedicines, Langen, Germany;z Allergan, Drug Safety Evaluation, 2525 Dupont Dr, RD-2A, Irvine, CA 92612-1599, USA;aa iMED, UL, University of Lisbon, Portugal;ab Millenium: The Takeda Oncology Company, 40 Landsdowne St., Cambridge, MA, USA;ac GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, UK;ad Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium;ae Medicines Healthcare Products Regulatory Agency (MHRA), UK
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