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Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
Davis, Jonathan M; Baer, Gerri R; McCune, Susan; Klein, Agnes; Sato, Junko; Fabbri, Laura; Mangili, Alexandra; Short, Mary A; Tansey, Susan; Mangum, Barry; Hokuto, Isamu; Nakamura, Hidefumi; Salaets, Thomas; Allegaert, Karel; Yao, Lynne; Blum, Michael; Toerner, Joseph; Turner, Mark; Portman, Ron.
Afiliação
  • Davis JM; The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA. Electronic address: jdavis@tuftsmedicalcenter.org.
  • Baer GR; US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD.
  • McCune S; US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD.
  • Klein A; Health Canada, Ottawa, Ontario, Canada.
  • Sato J; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Fabbri L; Chiesi Farmaceutici SpA, Parma, Italy.
  • Mangili A; Takeda Pharmaceutical Company Limited, Zug, Switzerland.
  • Short MA; Eli Lilly and Co, Indianapolis, IN.
  • Tansey S; Independent Consultant Pharmaceutical Physician, Durham, NC.
  • Mangum B; Paidion Research Inc, Durham, NC.
  • Hokuto I; St. Marianna University, Kawasaki, Japan.
  • Nakamura H; National Center for Child Health and Development, Tokyo, Japan.
  • Salaets T; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
  • Allegaert K; Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
  • Yao L; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
  • Blum M; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
  • Toerner J; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
  • Turner M; Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
  • Portman R; Novartis Pharmaceuticals, East Hanover, NJ.
J Pediatr ; 219: 243-249.e1, 2020 04.
Article em En | MEDLINE | ID: mdl-31708158
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Ensaios Clínicos como Assunto / Segurança do Paciente Limite: Humans / Newborn Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Ensaios Clínicos como Assunto / Segurança do Paciente Limite: Humans / Newborn Idioma: En Ano de publicação: 2020 Tipo de documento: Article