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"Simulect" as a model compound for assessing placental transfer of monoclonal antibodies in minipigs.

Autor: Hey A; Novartis Pharma AG, Switzerland. Electronic address: adam.hey@novartis.com., Hill M; Novartis Pharma AG, Switzerland., Calonder C; Novartis Pharma AG, Switzerland., DeLise AM; Novartis Pharma AG, USA., Grossi AB; Ellegaard Göttingen Minipigs A/S, Denmark., Pique C; Charles River Safety Assessment, Lyon, France., Marsden E; Charles River Safety Assessment, Lyon, France.

Publikováno v: Reproductive toxicology (Elmsford, N.Y.) [Reprod Toxicol] 2020 Jan; Vol. 91, pp. 142-146. Date of Electronic Publication: 2019 Nov 04.

Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

Autor: Solomon HM; GlaxoSmithKline, King of Prussia, PA, United States., Makris SL; U.S. Environmental Protection Agency, National Center for Environmental Assessment, Washington, DC, United States. Electronic address: makris.susan@epa.gov., Alsaid H; GlaxoSmithKline, King of Prussia, PA, United States., Bermudez O; ILSI Health and Environmental Sciences Institute, Washington, DC, United States., Beyer BK; Sanofi U.S. Inc., Bridgewater, NJ, United States., Chen A; Merck Research Laboratories, Kenilworth, NJ, United States., Chen CL; ILSI Health and Environmental Sciences Institute, Washington, DC, United States., Chen Z; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Chmielewski G; Covance Laboratories, Greenfield, IN, United States., DeLise AM; Novartis Pharmaceutical Corporation, East Hanover, NJ, United States., de Schaepdrijver L; Janssen R&D, Beerse, Belgium., Dogdas B; Merck Research Laboratories, Kenilworth, NJ, United States., French J; Morphology Consulting Ltd., Staffordshire, United Kingdom., Harrouk W; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Helfgott J; Stage 2 Innovations, Framingham, MI, United States., Henkelman RM; The Hospital for Sick Children, University of Toronto, Toronto, Canada., Hesterman J; InviCRO, Boston, MA, United States., Hew KW; Takeda Pharmaceutical Company, Deerfield, IL, United States., Hoberman A; Charles River Laboratories, Preclinical Services, Horsham, PA, United States., Lo CW; University of Pittsburgh, Pittsburgh, PA, United States., McDougal A; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Minck DR; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Scott L; Charles River Laboratories, Preclinical Services, Horsham, PA, United States., Stewart J; ApconiX, Macclesfield, Cheshire, United Kingdom., Sutherland V; National Toxicology Program/NIEHS, Research Triangle Park, NC, United States., Tatiparthi AK; Covance Laboratories, Greenfield, IN, United States., Winkelmann CT; Pfizer Worldwide Research & Development, La Jolla, CA, United States., Wise LD; Independent Teratologist, Philadelphia, PA, United States., Wood SL; Merck Research Laboratories, Upper Gwynedd, PA, United States., Ying X; Sanofi U.S. Inc., Cambridge, MA, United States.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2016 Jun; Vol. 77, pp. 100-8. Date of Electronic Publication: 2016 Feb 27.