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Tytuł :
Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
Autorzy :
Bercu, J.
Berlam, S. C.
Berridge, J.
Cherney, B.
Cowley, D.
Laughton, H. W.
McLoughlin, D.
McMahon, M.
Moore, C. M. V.
Murti, C.
O’Neill, J.
Parsons, R.
Peng, D. Y.Aff12, Aff13
Quan, R. W.
Subashi, A. K.
Teasdale, A.
Tyler, S. M.
Watson, T. J.
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Źródło :
Journal of Pharmaceutical Innovation: From R&D to Market. 14(1):76-89
Czasopismo naukowe
Tytuł :
A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.
Autorzy :
Bercu J; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Masuda-Herrera MJ; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Trejo-Martin A; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Hasselgren C; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Lord J; Ultragenyx, 60 Leveroni Court, Novato, CA, 94949, USA.
Graham J; Bristol Myers Squibb, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Schmitz M; AbbVie Inc., North Chicago, IL, USA.
Milchak L; 3M Company, 3M Center, St. Paul, MN, 55144-1000, USA.
Owens C; 3M Company, 3M Center, St. Paul, MN, 55144-1000, USA.
Lal SH; Syngenta Crop Protection, Product Safety Department, Jealott's Hill International Research Centre, Bracknell, Berkshire, RG42 6EY, UK(1).
Robinson RM; Syngenta Crop Protection, Product Safety Department, Jealott's Hill International Research Centre, Bracknell, Berkshire, RG42 6EY, UK(1).
Whalley S; Syngenta Crop Protection, Product Safety Department, Jealott's Hill International Research Centre, Bracknell, Berkshire, RG42 6EY, UK(1).
Bellion P; DSM Nutritional Products, Kaiseraugst, Switzerland.
Vuorinen A; DSM Nutritional Products, Kaiseraugst, Switzerland.
Gromek K; Galapagos SASU, 102 Avenue Gaston Roussel, 93230, Romainville, France.
Hawkins WA; GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, United Kingdom.
van de Gevel I; Janssen Pharmaceutical Companies of Johnson & Johnson, 2340, Beerse, Belgium.
Vriens K; Janssen Pharmaceutical Companies of Johnson & Johnson, 2340, Beerse, Belgium.
Kemper R; Vertex Pharmaceuticals Inc., Discovery and Investigative Toxicology, 50 Northern Ave, Boston, MA, USA.
Naven R; Vertex Pharmaceuticals Inc., Discovery and Investigative Toxicology, 50 Northern Ave, Boston, MA, USA.
Ferrer P; Department of Veterinary Physiology and Pharmacology, Interdisciplinary Faculty of Toxicology Program, Texas A&M University, 4466 TAMU, College Station, TX, 77843-4466, USA.
Myatt GJ; Leadscope (an Instem company), 1393 Dublin Rd, Columbus, OH, 43215, USA. Electronic address: .
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Mar; Vol. 120, pp. 104843. Date of Electronic Publication: 2020 Dec 17.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.
Autorzy :
Parris P; Pfizer Worldwide Research and Development, Sandwich, UK. Electronic address: .
Martin EA; AstraZeneca, Cambridge, UK.
Stanard B; Ultragenyx Pharmaceutical Inc., Novato, CA, USA.
Glowienke S; Novartis, Basel, Switzerland.
Dolan DG; Amgen Inc., Thousand Oaks, CA, USA.
Li K; Amgen Inc., Thousand Oaks, CA, USA.
Binazon O; GlaxoSmithKline, Wavre, Belgium.
Giddings A; GlaxoSmithKline, Hertfordshire, UK.
Whelan G; GlaxoSmithKline, Hertfordshire, UK.
Masuda-Herrera M; Gilead Sciences Inc., Foster City, CA, USA.
Bercu J; Gilead Sciences Inc., Foster City, CA, USA.
Broschard T; Merck Healthcare KGaA, Darmstadt, Germany.
Bruen U; Merck & Co., Inc., Kenilworth, NJ, USA.
Callis CM; Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN, USA.
Stults CLM; C & M Technical Consulting, LLC, USA.
Erexson GL; AbbVie, Inc., North Chicago, IL, USA.
Cruz MT; Faegre Drinker Biddle & Reath LLP, Washington, DC, USA.
Nagao LM; Faegre Drinker Biddle & Reath LLP, Washington, DC, USA.
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Dec; Vol. 118, pp. 104802. Date of Electronic Publication: 2020 Oct 07.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Management of pharmaceutical ICH M7 (Q)SAR predictions - The impact of model updates.
Autorzy :
Hasselgren C; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. Electronic address: .
Bercu J; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Cayley A; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, UK.
Cross K; Leadscope, Inc. an Instem Company, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Glowienke S; Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH-4057, Basel, Switzerland.
Kruhlak N; FDA Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
Muster W; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Nicolette J; AbbVie Inc., Pre-clinical Safety, 1 North Waukegan Road, North Chicago, IL, USA.
Reddy MV; Merck & Co., Inc., West Point, PA, 19486, USA.
Saiakhov R; Multicase Inc., 23811 Chagrin Boulevard, Suite 305, Beachwood, OH, 44122, USA.
Dobo K; Pfizer Worldwide Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Dec; Vol. 118, pp. 104807. Date of Electronic Publication: 2020 Oct 13.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Skin sensitization in silico protocol.
Autorzy :
Johnson C; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA. Electronic address: .
Ahlberg E; Bioinformatics Department, The University of Uppsala, 752 36, Uppsala, Sweden.
Anger LT; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Beilke L; Toxicology Solutions Inc., San Diego, CA, USA.
Benigni R; Alpha-PreTox, Via G.Pascoli 1, 00184, Roma, Italy.
Bercu J; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Bobst S; Toxsci Advisors LLC, 2016 Main Suite 1901, Houston, TX, USA.
Bower D; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Brigo A; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Campbell S; Nelson Laboratories, LLC, 6280 South Redwood Road, Salt Lake City, UT, 84123, USA.
Cronin MTD; School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.
Crooks I; British American Tobacco, Research and Development, Regents Park Road, Southampton, Hampshire, SO15 8TL, UK.
Cross KP; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Doktorova T; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, CH-4057, Basel / Basel-Stadt, Switzerland.
Exner T; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, CH-4057, Basel / Basel-Stadt, Switzerland.
Faulkner D; Chemical Sciences Division, Lawrence Berkeley National Lab, USA.
Fearon IM; whatIF? Consulting Ltd, The Crispin Burr Street, Harwell, OX11 0DT, UK.
Fehr M; DSM Nutritional Products, Kaiseraugst, Switzerland.
Gad SC; Gad Consulting Services, 4008 Barrett Drive, Suite 201, Raleigh, NC, 27609, USA.
Gervais V; Servier Group, 905 Route de Saran, 45520, Gidy, France.
Giddings A; GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, United Kingdom.
Glowienke S; Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH-4057, Basel, Switzerland.
Hardy B; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, CH-4057, Basel / Basel-Stadt, Switzerland.
Hasselgren C; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Hillegass J; Bristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Jolly R; Toxicology Division, Eli Lilly and Company, Indianapolis, IN, USA.
Krupp E; Sanofi, Corporate HSE, Global Product Steweardship, Industriepark Hoechst, D-65926, Frankfurt Am Main, Germany.
Lomnitski L; Perrigo Israel Pharmaceuticals Ltd, Shoham, Israel.
Magby J; Colgate-Palmolive Technology Center, 909 River Road, Piscataway, NJ, 08855, USA.
Mestres J; IMIM Hospital Del Mar Institute of Medical Research and University Pompeu Fabra, Doctor Aiguader 88, Parc de Recerca Biomèdica, 08003 Barcelona, Spain; and Chemotargets SL, Baldiri Reixac 4, Parc Científic de Barcelona, 08028, Barcelona, Spain.
Milchak L; 3M Company, St. Paul, MN, USA.
Miller S; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Muster W; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Neilson L; Broughton Nicotine Services, Oak Tree House, West Craven Drive, Earby, Lancashire, BB18 6JZ, UK.
Parakhia R; Church & Dwight Co., Inc, 469 North Harrison Street, Princeton, NJ, 08543, USA.
Parenty A; Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH-4057, Basel, Switzerland.
Parris P; Pfizer Worldwide Research and Development, Sandwich, UK.
Paulino A; ORO AGRI Europe, S.A, Palmela, Portugal.
Paulino AT; ORO AGRI Europe, S.A, Palmela, Portugal.
Roberts DW; Nelson Laboratories, LLC, 6280 South Redwood Road, Salt Lake City, UT, 84123, USA.
Schlecker H; Bayer AG, Research & Development, Pharmaceuticals, Industrial Chemicals Toxicology & Genetic Toxicology, 42096, Wuppertal, Germany.
Stidl R; Safetree Consulting e.U, Vienna, Austria.
Suarez-Rodrigez D; FStox Consulting LTD, 2 Brooks Road, Raunds, Wellingborough, NN9 6NS, UK.
Szabo DT; PPG Industries, Pittsburgh, PA, 15146, USA.
Tice RR; RTice Consulting, Hillsborough, NC, 27278, USA.
Urbisch D; BASF SE, Product Safety, Carl-Bosch-Strasse 38, 67056, Ludwigshafen Am Rhein, Germany.
Vuorinen A; DSM Nutritional Products, Kaiseraugst, Switzerland.
Wall B; Colgate-Palmolive Technology Center, 909 River Road, Piscataway, NJ, 08855, USA.
Weiler T; Servier Group, 905 Route de Saran, 45520, Gidy, France.
White AT; GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, United Kingdom.
Whritenour J; Pfizer Inc., Drug Safety Research and Development, Eastern Point Road, Groton, CT, 06340, USA.
Wichard J; Bayer AG, Research & Development, Pharmaceuticals, Industrial Chemicals Toxicology & Genetic Toxicology, 42096, Wuppertal, Germany.
Woolley D; ForthTox Limited, PO Box 13550, Linlithgow, EH49 7YU, UK.
Zwickl C; Transendix LLC, 1407 Moores Manor, Indianapolis, IN, 46229, USA.
Myatt GJ; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Oct; Vol. 116, pp. 104688. Date of Electronic Publication: 2020 Jul 01.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Genetic toxicology in silico protocol.
Autorzy :
Hasselgren C; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. Electronic address: .
Ahlberg E; Predictive Compound ADME & Safety, Drug Safety & Metabolism, AstraZeneca IMED Biotech Unit, Mölndal, Sweden.
Akahori Y; Chemicals Evaluation and Research Institute, 1-4-25 Kouraku, Bunkyo-ku, Tokyo, 112-0004, Japan.
Amberg A; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.
Anger LT; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.
Atienzar F; UCB BioPharma SPRL, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Auerbach S; The National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, 27709, USA.
Beilke L; Toxicology Solutions Inc., San Diego, CA, USA.
Bellion P; DSM Nutritional Products, Kaiseraugst, Switzerland.
Benigni R; Alpha-PreTox, via G.Pascoli 1, 00184, Roma, Italy.
Bercu J; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Booth ED; Syngenta, Product Safety Department, Jealott's Hill International Research Centre, Bracknell, Berkshire, RG42 6EY, UK.
Bower D; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Brigo A; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Cammerer Z; Janssen Research & Development, 1400 McKean Road, Spring House, PA, 19477, USA.
Cronin MTD; School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.
Crooks I; British American Tobacco, Research and Development, Regents Park Road, Southampton, Hampshire, SO15 8TL, UK.
Cross KP; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Custer L; Bristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Dobo K; Pfizer Global Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
Doktorova T; Douglas Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, CH-4057, Basel / Basel-Stadt, Switzerland.
Faulkner D; Lawrence Berkeley National Laboratory, One Cyclotron Road, MS 70A-1161A, Berkeley, CA, 947020, USA.
Ford KA; Global Blood Therapeutics, 171 Oyster Point Boulevard, South San Francisco, CA, 94080, USA.
Fortin MC; Jazz Pharmaceuticals, Inc., 200 Princeton South Corporate Center, Suite 180, Ewing, NJ, 08628, USA; Department of Pharmacology and Toxicology, Ernest Mario School of Pharmacy, Rutgers University, 170 Frelinghuysen Rd, Piscataway, NJ, 08855, USA.
Frericks M; BASF SE, 67056, Ludwigshafen, Germany.
Gad-McDonald SE; Gad Consulting Services, 4008 Barrett Drive, Suite 201, Raleigh, NC, 27609, 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.
Gerets H; UCB BioPharma SPRL, Chemin du Foriest, B-1420, Braine-l'Alleud, Belgium.
Gervais V; Servier Group, 905 route de Saran, 45520, Gidy, France.
Glowienke S; Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH, 4057, Basel, Switzerland.
Van Gompel J; Janssen Pharmaceutical Companies of Johnson & Johnson, 2340, Beerse, Belgium.
Harvey JS; GlaxoSmithKline Pre-Clinical Development, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
Hillegass J; Bristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Honma M; Division of Genetics and Mutagenesis, National Institute of Health Sciences, Kanagawa, 210-9501, Japan.
Hsieh JH; Kelly Government Solutions, Research Triangle Park, NC, 27709, USA.
Hsu CW; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Barton-Maclaren TS; Existing Substances Risk Assessment Bureau, Health Canada, Ottawa, ON, K1A 0K9, Canada.
Johnson C; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Jolly R; Toxicology Division, Eli Lilly and Company, Indianapolis, IN, USA.
Jones D; Medicines and Healthcare Products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Kemper R; Vertex Pharmaceuticals Inc., Predictive and Investigative Safety Assessment, 50 Northern Ave, Boston, MA, USA.
Kenyon MO; Pfizer Global Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
Kruhlak NL; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Kulkarni SA; Existing Substances Risk Assessment Bureau, Health Canada, Ottawa, ON, K1A 0K9, Canada.
Kümmerer K; Institute for Sustainable and Environmental Chemistry, Leuphana University Lüneburg, Scharnhorststraße 1/C13.311b, 21335, Lüneburg, Germany.
Leavitt P; Bristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Masten S; The National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, 27709, USA.
Miller S; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Moudgal C; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Muster W; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Paulino A; Oro Agri Setúbal, Portugal.
Lo Piparo E; Nestlé Research Vers-chez-les-Blanc, Lausanne, Switzerland.
Powley M; Merck Research Laboratories, West Point, PA, 19486, USA.
Quigley DP; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
Reddy MV; Merck Research Laboratories, West Point, PA, 19486, USA.
Richarz AN; European Commission, Joint Research Centre (JRC), Ispra, Italy.
Schilter B; Nestlé Research Vers-chez-les-Blanc, Lausanne, Switzerland.
Snyder RD; RDS Consulting Services, 2936 Wooded Vista Ct, Mason, OH, 45040, USA.
Stavitskaya L; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Stidl R; Safetree Consulting e.U, Vienna, Austria.
Szabo DT; PPG Industries, Pittsburgh, PA, 15146, USA.
Teasdale A; AstraZeneca, Macclesfield, Cheshire, UK.
Tice RR; RTice Consulting, Hillsborough, NC, USA.
Trejo-Martin A; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Vuorinen A; DSM Nutritional Products, Kaiseraugst, Switzerland.
Wall BA; Colgate-Palmolive Company, Piscataway, NJ, 08854, USA.
Watts P; Bibra, Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK.
White AT; GlaxoSmithKline Pre-Clinical Development, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
Wichard J; Bayer AG, Pharmaceuticals Division, Investigational Toxicology, Muellerstr. 178, D-13353, Berlin, Germany.
Witt KL; The National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, 27709, USA.
Woolley A; ForthTox Limited, PO Box 13550, Linlithgow, EH49 7YU, UK.
Woolley D; ForthTox Limited, PO Box 13550, Linlithgow, EH49 7YU, UK.
Zwickl C; Transendix LLC, 1407 Moores Manor, Indianapolis, IN, 46229, USA.
Myatt GJ; Leadscope, Inc, 1393 Dublin Rd, Columbus, OH, 43215, USA.
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2019 Oct; Vol. 107, pp. 104403. Date of Electronic Publication: 2019 Jun 11.
Typ publikacji :
Journal Article
MeSH Terms :
Models, Theoretical*
Research Design*
Mutagens/*toxicity
Toxicology/*methods
Animals ; Computer Simulation ; Humans ; Mutagenicity Tests ; Risk Assessment
Czasopismo naukowe
Tytuł :
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?
Autorzy :
Amberg A; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Höchst, Frankfurt am Main, Germany.
Anger LT; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Höchst, Frankfurt am Main, Germany.
Bercu J; Gilead Sciences, Nonclinical Safety and Pathobiology, Foster City, CA, USA.
Bower D; Leadscope, Inc., Columbus, OH, USA.
Cross KP; Leadscope, Inc., Columbus, OH, USA.
Custer L; Bristol-Myers Squibb, Drug Safety Evaluation, New Brunswick, NJ, USA.
Harvey JS; GlaxoSmithKline Pre-Clinical Development, Ware, Hertfordshire, UK.
Hasselgren C; Genentech, Inc., Safety Assessment, South San Francisco, CA, USA.
Honma M; National Institute of Health Sciences, Division of Genetics & Mutagenesis, Kamiyoga, Setagaya-ku, Tokyo, Japan.
Johnson C; Leadscope, Inc., Columbus, OH, USA.
Jolly R; Toxicology Division, Eli Lilly and Company, Indianapolis, IN, USA.
Kenyon MO; Pfizer Worldwide Research and Development, Drug Safety, Genetic Toxicology, Groton, CT, USA.
Kruhlak NL; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Leavitt P; Bristol-Myers Squibb, Drug Safety Evaluation, New Brunswick, NJ, USA.
Quigley DP; Leadscope, Inc., Columbus, OH, USA.
Miller S; Leadscope, Inc., Columbus, OH, USA.
Snodin D; Xiphora Biopharma Consulting, Bristol, UK.
Stavitskaya L; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Teasdale A; AstraZeneca, Pharmaceutical Technology and Development, Macclesfield, Cheshire, UK.
Trejo-Martin A; AstraZeneca, Pharmaceutical Technology and Development, Macclesfield, Cheshire, UK.
White AT; GlaxoSmithKline Pre-Clinical Development, Ware, Hertfordshire, UK.
Wichard J; Bayer AG, Pharmaceuticals Division, Investigational Toxicology, Muellerstr, Berlin, Germany.
Myatt GJ; Leadscope, Inc., Columbus, OH, USA.
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Źródło :
Mutagenesis [Mutagenesis] 2019 Mar 06; Vol. 34 (1), pp. 67-82.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms :
Quantitative Structure-Activity Relationship*
Cyclic N-Oxides/*chemistry
DNA Damage/*drug effects
Mutagens/*chemistry
Cyclic N-Oxides/toxicity ; Mutagenesis/drug effects ; Mutagenicity Tests ; Mutagens/toxicity
Czasopismo naukowe
Tytuł :
Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses.
Autorzy :
Amberg A; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.
Andaya RV; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Anger LT; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.
Barber C; Lhasa Limited, Leeds, UK.
Beilke L; Toxicology Solutions Inc., San Diego, CA, USA.
Bercu J; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Bower D; Leadscope, Inc., 1393 Dublin Rd, Columbus, OH, 43215, USA.
Brigo A; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland.
Cammerer Z; Janssen Research & Development, 1400 McKean Road, Spring House, PA, 19477, USA.
Cross KP; Leadscope, Inc., 1393 Dublin Rd, Columbus, OH, 43215, USA.
Custer L; Bristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Dobo K; Pfizer Global Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
Gerets H; UCB Biopharma SPRL, Chemin du Foriest, B-1420, Braine-l'Alleud, Belgium.
Gervais V; Servier Group, Gidy, France.
Glowienke S; Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH-4057, Basel, Switzerland.
Gomez S; Consultant to Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.
Van Gompel J; Janssen Pharmaceutical Companies of Johnson & Johnson, 2340, Beerse, Belgium.
Harvey J; GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
Hasselgren C; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Honma M; National Institute of Health Sciences, Tokyo, Japan.
Johnson C; Leadscope, Inc., 1393 Dublin Rd, Columbus, OH, 43215, USA.
Jolly R; Toxicology Division, Eli Lilly and Company, Indianapolis, IN, USA.
Kemper R; Vertex Pharmaceuticals Inc., Discovery and Investigative Toxicology, 50 Northern Ave, Boston, MA, USA.
Kenyon M; Pfizer Global Research & Development, 558 Eastern Point Road, Groton, CT, 06340, USA.
Kruhlak N; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Leavitt P; Bristol-Myers Squibb, Drug Safety Evaluation, 1 Squibb Dr, New Brunswick, NJ, 08903, USA.
Miller S; Leadscope, Inc., 1393 Dublin Rd, Columbus, OH, 43215, USA.
Muster W; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland.
Naven R; Takeda, Cambridge, MA, USA.
Nicolette J; AbbVie Inc., North Chicago, IL, USA.
Parenty A; Novartis Pharma AG, Pre-Clinical Safety, Werk Klybeck, CH-4057, Basel, Switzerland.
Powley M; Merck Research Laboratories, West Point, PA, 19486, USA.
Quigley DP; Leadscope, Inc., 1393 Dublin Rd, Columbus, OH, 43215, USA.
Reddy MV; Merck Research Laboratories, West Point, PA, 19486, USA.
Sasaki JC; Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Stavitskaya L; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Teasdale A; AstraZeneca, Macclesfield, Cheshire, UK.
Trejo-Martin A; Gilead Sciences, 333 Lakeside Drive, Foster City, CA, USA.
Weiner S; Janssen Research & Development, 1400 McKean Road, Spring House, PA, 19477, USA.
Welch DS; AbbVie Inc., North Chicago, IL, USA.
White A; GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
Wichard J; Bayer Pharma AG, Investigational Toxicology, Muellerstr. 178, D-13353, Berlin, Germany.
Woolley D; ForthTox Limited, PO Box 13550, Linlithgow, EH49 7YU, UK.
Myatt GJ; Leadscope, Inc., 1393 Dublin Rd, Columbus, OH, 43215, USA. Electronic address: .
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2019 Mar; Vol. 102, pp. 53-64. Date of Electronic Publication: 2018 Dec 15.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Contamination*
Guidelines as Topic*
Quantitative Structure-Activity Relationship*
Mutagens/*classification
Drug Industry ; Government Agencies ; Mutagens/toxicity ; Risk Assessment
Czasopismo naukowe

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