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Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.

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Title: Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.
Authors: Schanberg LE; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina., Mulugeta LY; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Akinlade B; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Brunner HI; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Chen J; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Colbert RA; Intramural Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland., Delgaizo V; CARRA, Inc., Washington, DC., Gastonguay MR; Metrum Research Group, Tariffville, Connecticut., Glaser R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Imundo L; Columbia University Irving Medical Center, New York, New York., Lovell DJ; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Leu JH; Janssen Research and Development, Spring House, Pennsylvania., Mostafa NM; AbbVie, North Chicago, Illinois., Nelson RM; Johnson & Johnson, New Brunswick, New Jersey., Nigrovic PA; Division of Immunology, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School and Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Department of Medicine, Harvard Medical School, Boston, Massachusetts., Nikolov NP; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Rider LG; Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences, NIH, Bethesda, Maryland., Rothwell R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Sahajwalla C; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Singh R; Gilead Sciences, Foster City, California., Sinha V; Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover NJ, 07936, USA., Yancey CL; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Yao L; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Source: Arthritis & rheumatology (Hoboken, N.J.) [Arthritis Rheumatol] 2023 Oct; Vol. 75 (10), pp. 1856-1866. Date of Electronic Publication: 2023 Aug 03.
Publication Type: Journal Article
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 101623795 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2326-5205 (Electronic) Linking ISSN: 23265191 NLM ISO Abbreviation: Arthritis Rheumatol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.
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  Data: <searchLink fieldCode="AU" term="%22Schanberg+LE%22">Schanberg LE</searchLink>; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.<br /><searchLink fieldCode="AU" term="%22Mulugeta+LY%22">Mulugeta LY</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Akinlade+B%22">Akinlade B</searchLink>; Regeneron Pharmaceuticals, Inc., Tarrytown, New York.<br /><searchLink fieldCode="AU" term="%22Brunner+HI%22">Brunner HI</searchLink>; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.<br /><searchLink fieldCode="AU" term="%22Chen+J%22">Chen J</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Colbert+RA%22">Colbert RA</searchLink>; Intramural Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.<br /><searchLink fieldCode="AU" term="%22Delgaizo+V%22">Delgaizo V</searchLink>; CARRA, Inc., Washington, DC.<br /><searchLink fieldCode="AU" term="%22Gastonguay+MR%22">Gastonguay MR</searchLink>; Metrum Research Group, Tariffville, Connecticut.<br /><searchLink fieldCode="AU" term="%22Glaser+R%22">Glaser R</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Imundo+L%22">Imundo L</searchLink>; Columbia University Irving Medical Center, New York, New York.<br /><searchLink fieldCode="AU" term="%22Lovell+DJ%22">Lovell DJ</searchLink>; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.<br /><searchLink fieldCode="AU" term="%22Leu+JH%22">Leu JH</searchLink>; Janssen Research and Development, Spring House, Pennsylvania.<br /><searchLink fieldCode="AU" term="%22Mostafa+NM%22">Mostafa NM</searchLink>; AbbVie, North Chicago, Illinois.<br /><searchLink fieldCode="AU" term="%22Nelson+RM%22">Nelson RM</searchLink>; Johnson & Johnson, New Brunswick, New Jersey.<br /><searchLink fieldCode="AU" term="%22Nigrovic+PA%22">Nigrovic PA</searchLink>; Division of Immunology, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School and Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Department of Medicine, Harvard Medical School, Boston, Massachusetts.<br /><searchLink fieldCode="AU" term="%22Nikolov+NP%22">Nikolov NP</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Rider+LG%22">Rider LG</searchLink>; Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences, NIH, Bethesda, Maryland.<br /><searchLink fieldCode="AU" term="%22Rothwell+R%22">Rothwell R</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Sahajwalla+C%22">Sahajwalla C</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Singh+R%22">Singh R</searchLink>; Gilead Sciences, Foster City, California.<br /><searchLink fieldCode="AU" term="%22Sinha+V%22">Sinha V</searchLink>; Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover NJ, 07936, USA.<br /><searchLink fieldCode="AU" term="%22Yancey+CL%22">Yancey CL</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Yao+L%22">Yao L</searchLink>; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
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  Data: <searchLink fieldCode="JN" term="%22101623795%22">Arthritis & rheumatology (Hoboken, N.J.)</searchLink> [Arthritis Rheumatol] 2023 Oct; Vol. 75 (10), pp. 1856-1866. <i>Date of Electronic Publication: </i>2023 Aug 03.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Wiley%22">Wiley </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101623795 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2326-5205 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2223265191%22">23265191 </searchLink><i>NLM ISO Abbreviation: </i>Arthritis Rheumatol <i>Subsets: </i>MEDLINE
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