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Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.
Prior, Helen; Baldrick, Paul; Beken, Sonja; Booler, Helen; Bower, Nancy; Brooker, Paul; Brown, Paul; Burlinson, Brian; Burns-Naas, Leigh Ann; Casey, Warren; Chapman, Melissa; Clarke, David; de Haan, Lolke; Doehr, Olaf; Downes, Noel; Flaherty, Meghan; Gellatly, Nichola; Moesgaard, Sophia Gry; Harris, Jennifer; Holbrook, Mark; Hui, Julia; Jones, David; Jones, Keith; Kedar, Hilla; Mahl, Andreas; Manninen, Alli; McGuire, Aidan; Mortimer-Cassen, Elisabeth; Peraza, Marjorie; Pugsley, Michael K; Richard, Jacques; Roberts, Ruth; Roosen, Wendy; Rothfuss, Andreas; Schoenmakers, Ankie; Sewell, Fiona; Weaver, Richard; Weir, Lucinda; Wolfreys, Alison; Kimber, Ian.
Afiliação
  • Prior H; National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK. Electronic address: helen.prior@nc3rs.org.uk.
  • Baldrick P; Covance Laboratories Ltd, Otley Road, Harrogate, HG3 1PY, UK.
  • Beken S; Federal Agency for Medicines and Health Products (FAMHP), Victor Hortaplace 40/40, Brussels, 1060, Belgium.
  • Booler H; Genentech, Inc, 1 DNA Way, South San Francisco, CA, 94080, USA.
  • Bower N; Eisai Inc, 155 Tice Blvd, Woodcliff Lake, NJ, 07677, USA.
  • Brooker P; Board member, NC3Rs, Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.
  • Brown P; Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
  • Burlinson B; Covance, Huntingdon, Cambridgeshire, PE28 4HS, UK.
  • Burns-Naas LA; Gilead Sciences, Inc, 333 Lakeside Drive, Foster City, CA, 94404, USA.
  • Casey W; National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), National Institute of Environmental Health Sciences, P.O. Box 12233, Research Triangle Park, NC, 27709, USA.
  • Chapman M; Oncology Safety, Clinical Pharmacology and Safety Sciences,R&D, AstraZeneca, Cambridge, UK.
  • Clarke D; Lilly Research Laboratories, Indianapolis, IN, 46285, USA.
  • de Haan L; Biologics and Advanced Therapeutics Safety, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.
  • Doehr O; Bayer Pharma AG, Müllerstrasse 170, 13353, Berlin, Germany.
  • Downes N; Sequani Limited, Bromyard Rd, Ledbury, Herefordshire, HR8 1LH, UK.
  • Flaherty M; Takeda Pharmaceuticals, 300 Massachusetts Ave, Cambridge, MA, 02139, USA.
  • Gellatly N; National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.
  • Moesgaard SG; Novo Nordisk A/S, Novo Nordisk Park, Maaloev, Denmark.
  • Harris J; Association of British Pharmaceutical Industry (ABPI), 105 Victoria Street, London, SW1E 6QT, UK.
  • Holbrook M; VAST Pharma Solutions Ltd, Harrogate, UK.
  • Hui J; Celgene, 86 Morris Avenue, Summit, NJ, 07901, USA.
  • Jones D; Medicines Healthcare products Regulatory Agency (MHRA) 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
  • Jones K; CFMD Ltd, Peterborough, UK.
  • Kedar H; Teva Pharmaceuticals, Netanya Area, Israel.
  • Mahl A; Novartis Institutes for BioMedical Research (NIBR), Basel, Switzerland.
  • Manninen A; Prekliniska Byran Sweden AB, Stockholm, Sweden.
  • McGuire A; Charles River Laboratories, Preclinical Services, Tranent, Edinburgh, EH33 2NE, UK.
  • Mortimer-Cassen E; Regulatory Safety Centre of Excellence, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.
  • Peraza M; Pfizer Drug Safety Research and Development, 300 Technology Square, Cambridge, MA, 02139, USA.
  • Pugsley MK; Cytokinetics, South San Francisco, CA, 94080, USA.
  • Richard J; Sanofi, 371 Rue du Professeur Blayac, Montpellier, 34000, France.
  • Roberts R; ApconiX, Alderley Park, Alderley Edge, Cheshire, SK10 4TG, UK.
  • Roosen W; Janssen Research & Development, Turnhoutseweg 30, 2340, Beerse, Belgium.
  • Rothfuss A; Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, CH - 4070, Basel, Switzerland.
  • Schoenmakers A; Charles River Laboratories, Den Bosch B.V, the Netherlands.
  • Sewell F; National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.
  • Weaver R; Institut de Recherches Internationales Servier, Biopharmacy, 92284, Suresnes, Cedex, France.
  • Weir L; GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
  • Wolfreys A; UCB Biopharma, Bath Rd, Slough, SL1 3WE, UK.
  • Kimber I; University of Manchester, Faculty of Biology, Medicine and Health, Oxford Rd, Manchester, M13 9PL, UK.
Regul Toxicol Pharmacol ; 113: 104624, 2020 Jun.
Article em En | MEDLINE | ID: mdl-32126256
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Testes de Toxicidade / Avaliação Pré-Clínica de Medicamentos / Desenvolvimento de Medicamentos Tipo de estudo: Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Testes de Toxicidade / Avaliação Pré-Clínica de Medicamentos / Desenvolvimento de Medicamentos Tipo de estudo: Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2020 Tipo de documento: Article