Zobrazeno 1 - 10 of 346 pro vyhledávání: '"Herzyk, D."'
1
Akademický článek
Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis.
Autor: Pallardy M; Université Paris-Saclay, INSERM, Inflammation Microbiome Immunosurveillance, Orsay, 91400, France., Bechara R; Université Paris-Saclay, INSERM, CEA, Center for Research in Immunology of Viral, Autoimmune, Hematological and Bacterial Diseases (IMVA-HB), Le Kremlin Bicêtre, 94270, France., Whritenour J; Pfizer Worldwide Research, Development and Medical, Groton, Connecticut 06340, USA., Mitchell-Ryan S; The Health and Environmental Science Institute, Immunosafety Technical Committee, Washington, District of Columbia 20005, USA., Herzyk D; Merck & Co., Inc, West Point, Pennsylvania 19486, USA., Lebrec H; Amgen Inc., Translational Safety and Bioanalytical Sciences, South San Francisco, California 94080, USA., Merk H; Department of Dermatology and Allergology, RWTH Aachen University, Aachen, 52062, Germany., Gourley I; Janssen Research & Development, LLC, Immunology Clinical Development, Spring House, Pennsylvania 19002, USA., Komocsar WJ; Immunology Business Unit, Eli Lilly and Company, Indianapolis, Indiana 46225, USA., Piccotti JR; Drug Discovery, Schrodinger, Inc, San Diego, California 92121, USA., Balazs M; Genentech, Biochemical and Cellular Pharmacology, South San Francisco, California 94080, USA., Sharma A; Pfizer, Drug Safety Research & Development, New York 10017, USA., Walker DB; Novartis Institute for Biomedical Research, Preclinical Safety-Translational Immunology and Clinical Pathology, Cambridge, Massachusetts 02139, USA., Weinstock D; Janssen Research & Development, LLC, Preclinical Sciences Translational Safety, Spring House, Pennsylvania 19002, USA.
Publikováno v: Toxicological sciences : an official journal of the Society of Toxicology [Toxicol Sci] 2024 Jun 26; Vol. 200 (1), pp. 11-30.
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2
Akademický článek
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Autor: Prior H; National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs), London, UK. Electronic address: helen.prior@nc3rs.org.uk., Andrews L; AbbVie, Worcester, MA, USA., Cauvin A; UCB BioPharma, Brussels, Belgium., Chien H; Medicine Evaluation Board, Utrecht, the Netherlands., Clarke DO; Lilly Corporate Center, Indianapolis, IN, USA., Datta K; Bristol Myers Squibb, Nonclinical Research and Development, New Jersey, USA., Dempster M; GlaxoSmithKline, King of Prussia, PA, USA., Dybdal N; Genentech, South San Francisco, CA, USA., Freebern W; Janssen Inc., Spring House, PA, USA., de Haan L; ADC Therapeutics, I-HUB, Imperial College White City Campus, London, UK., Herzyk D; Merck & Co., Inc., West Point, PA, USA., Hey A; AstraZeneca, Cambridge, UK., Kissner T; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany., Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland., Leach MW; Pfizer Inc., Cambridge, MA, USA., Lee D; Genentech, South San Francisco, CA, USA., Reid K; European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium., Schutte K; European Commission, Brussels, Belgium., Sewell F; National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs), London, UK., Trouba K; Janssen Inc., Spring House, PA, USA., Ulrich P; Novartis Institutes for BioMedical Research, Basel, Switzerland., van Aerts L; Medicine Evaluation Board, Utrecht, the Netherlands., van Meer P; Medicine Evaluation Board, Utrecht, the Netherlands., Weir L; GlaxoSmithKline, Ware, Hertfordshire, UK.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Feb; Vol. 138, pp. 105339. Date of Electronic Publication: 2023 Jan 14.
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3
Akademický článek
FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.
Autor: Ackley D; Eli Lilly and Co. Inc., Lilly Corporate Center, Indianapolis, IN, 46285, USA., Birkebak J; Gilead Sciences Inc., 333 Lakeside Dr, Foster City, CA, 94404, USA. Electronic address: joanne.birkebak@gilead.com., Blumel J; Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA., Bourcier T; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., de Zafra C; Seagen, 21823 30th Drive SE, Bothell, WA, 98021, USA., Goodwin A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Halpern W; Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA., Herzyk D; Merck & Co., Inc., West Point, PA, USA., Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland., Mauthe R; Pfizer Inc., 445 Eastern Point Road, Groton, CT, 06340, USA., Shenton J; Amgen Inc., Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA, USA., Shuey D; Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE, USA., Wange RL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Feb; Vol. 138, pp. 105327. Date of Electronic Publication: 2022 Dec 28.
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4
Akademický článek
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Autor: Chien HT; Medicines Evaluation Board, Utrecht, the Netherlands; Radboud University Medical Center, Nijmegen, the Netherlands., Prior H; National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs), London, UK., Andrews L; AbbVie, Worcester, MA, USA., van Aerts L; Medicines Evaluation Board, Utrecht, the Netherlands., Cauvin A; UCB BioPharma, Brussels, Belgium., Clarke DO; Lilly Corporate Center, Indianapolis, IN, USA., Datta K; Bristol Myers Squibb, Nonclinical Research and Development, New Jersey, USA., Dempster M; GlaxoSmithKline, King of Prussia, PA, USA., Dybdal N; Genentech, South San Francisco, CA, USA., Freebern W; Janssen Inc., Spring House, PA, USA., de Haan L; ADC Therapeutics, I-HUB, Imperial College White City Campus, London, UK., Herzyk D; Merck & Co., Inc., West Point, PA, USA., Hey A; AstraZeneca, Cambridge, UK., Kissner T; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany., Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland., Leach MW; Pfizer Inc., Cambridge, MA, USA., Lee D; Genentech, South San Francisco, CA, USA., Schutte K; European Commission, Brussels, Belgium., Sewell F; National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs), London, UK., Trouba K; Janssen Inc., Spring House, PA, USA., Ulrich P; Novartis Institutes for BioMedical Research, Basel, Switzerland., Weir L; GlaxoSmithKline, Ware, Hertfordshire, UK., van Meer P; Medicines Evaluation Board, Utrecht, the Netherlands. Electronic address: p.v.meer@cbg-meb.nl.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Feb; Vol. 138, pp. 105329. Date of Electronic Publication: 2022 Dec 30.
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6
Akademický článek
The Role of the Basophil Activation Test in the Diagnosis of Drug-Induced Anaphylaxis.
Autor: Czarnobilska, Maria1 (AUTHOR) maria.czarnobilska@uj.edu.pl, Bulanda, Małgorzata2 (AUTHOR) gosia.lesniak@uj.edu.pl, Czarnobilska, Ewa2 (AUTHOR) ewa.czarnobilska@uj.edu.pl, Dyga, Wojciech2 (AUTHOR) wojciech.dyga@uj.edu.pl, Mazur, Marcel2 (AUTHOR) marcel.mazur@uj.edu.pl
Publikováno v: Diagnostics (2075-4418). Sep2024, Vol. 14 Issue 18, p2036. 14p.
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7
Akademický článek
Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies.
Autor: MacLachlan TK; Department of Preclinical Safety, Novartis Institutes for Biomedical Research, Cambridge, MA, 02139, USA. Electronic address: timothy.maclachlan@novartis.com., Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, 4070, Basel, Switzerland., Marshall N; Non-Clinical Safety, GlaxoSmithKline, 1250 South Collegeville RD, Collegeville, PA, 19426, USA., Andrews L; Abbvie Preclinical Safety, Worcester, MA, USA, 01605., Berens SJ; Investigative Toxicology and Pathology, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, 46285, USA., Brouta F; UCB Biopharma SRL, Non-Clinical Safety Evaluation, 1420, Braine-l'Alleud, Belgium., Fogal B; Nonclinical Drug Safety, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, 06877, USA., Freebern W; Bristol Myers Squibb, Drug Safety Evaluation, New Brunswick, NJ, 08903, USA., Herzyk D; Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA., Kamperschroer C; Pfizer Worldwide Research & Development, Groton, CT, USA., Kiessling A; Department of Preclinical Safety, Novartis Institutes for Biomedical Research, Basel, Switzerland., Schneidkraut M; Astellas Discovery Science and Management, 1 Astellas Way, N2.103, Northbrook, IL, 60062, USA., Maier C; Non-Clinical Safety, GlaxoSmithKline, 1250 South Collegeville RD, Collegeville, PA, 19426, USA.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Feb; Vol. 119, pp. 104825. Date of Electronic Publication: 2020 Nov 19.
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8
Akademický článek
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab.
Autor: Hutchins B; Merck & Co., Inc., Kenilworth, New Jersey. beth.hutchins@merck.com., Starling GC; Merck & Co., Inc., Kenilworth, New Jersey., McCoy MA; Merck & Co., Inc., Kenilworth, New Jersey., Herzyk D; Merck & Co., Inc., Kenilworth, New Jersey., Poulet FM; Merck & Co., Inc., Kenilworth, New Jersey., Dulos J; Merck & Co., Inc., Kenilworth, New Jersey.; Galapagos, Leiden, The Netherlands., Liu L; Merck & Co., Inc., Kenilworth, New Jersey., Kang SP; Merck & Co., Inc., Kenilworth, New Jersey., Fayadat-Dilman L; Merck & Co., Inc., Kenilworth, New Jersey., Hsieh M; Merck & Co., Inc., Kenilworth, New Jersey., Andrews CL; Merck & Co., Inc., Kenilworth, New Jersey., Ayanoglu G; Merck & Co., Inc., Kenilworth, New Jersey., Cullen C; Merck & Co., Inc., Kenilworth, New Jersey.; Apollo Biologics Consulting, Los Angeles, California., Malefyt RW; Merck & Co., Inc., Kenilworth, New Jersey.; Synthekine, Inc., Menlo Park, California., Kastelein RA; Merck & Co., Inc., Kenilworth, New Jersey.; Synthekine, Inc., Menlo Park, California., Saux SL; Merck & Co., Inc., Kenilworth, New Jersey., Lee J; Merck & Co., Inc., Kenilworth, New Jersey., Li S; Merck & Co., Inc., Kenilworth, New Jersey., Malashock D; Merck & Co., Inc., Kenilworth, New Jersey., Sadekova S; Merck & Co., Inc., Kenilworth, New Jersey., Soder G; Merck & Co., Inc., Kenilworth, New Jersey., van Eenennaam H; Merck & Co., Inc., Kenilworth, New Jersey.; AIMM Therapeutics B.V., Amsterdam, The Netherlands., Willingham A; Merck & Co., Inc., Kenilworth, New Jersey., Yu Y; Merck & Co., Inc., Kenilworth, New Jersey., Streuli M; Merck & Co., Inc., Kenilworth, New Jersey.; Pionyr Immunotherapeutics, South San Francisco, California., Carven GJ; Merck & Co., Inc., Kenilworth, New Jersey.; Scholar Rock, Inc., Cambridge, Massachusetts., van Elsas A; Merck & Co., Inc., Kenilworth, New Jersey.; Aduro Biotech, Inc., Berkeley, California.
Publikováno v: Molecular cancer therapeutics [Mol Cancer Ther] 2020 Jun; Vol. 19 (6), pp. 1298-1307. Date of Electronic Publication: 2020 Mar 30.
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10
Akademický článek
Nonclinical safety of tildrakizumab, a humanized anti-IL-23p19 monoclonal antibody, in nonhuman primates.
Autor: Santostefano M; Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., 33 Avenue Louis Pasteur, Boston, MA, 02115-5727, United States. Electronic address: michael.santostefano@merck.com., Herzyk D; Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA, 19486, United States. Electronic address: danuta_herzyk@merck.com., Montgomery D; Pharmacokinetics, Predictive and Clinical Immunogenicity, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA, 19486, United States. Electronic address: diana.montgomery@merck.com., Wolf J; Global Regulatory Affairs, Merck & Co., Inc., 351 N. Sumneytown Pike, North Wales, PA, 19454-2505, United States. Electronic address: jayanthi.wolf@merck.com.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2019 Nov; Vol. 108, pp. 104476. Date of Electronic Publication: 2019 Sep 16.
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