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The benefits, limitations and opportunities of preclinical models for neonatal drug development.
Campion, Sarah; Inselman, Amy; Hayes, Belinda; Casiraghi, Costanza; Joseph, David; Facchinetti, Fabrizio; Salomone, Fabrizio; Schmitt, Georg; Hui, Julia; Davis-Bruno, Karen; Van Malderen, Karen; Morford, LaRonda; De Schaepdrijver, Luc; Wiesner, Lutz; Kourula, Stephanie; Seo, Suna; Laffan, Susan; Urmaliya, Vijay; Chen, Connie.
Afiliação
  • Campion S; Pfizer Worldwide Research, Development, and Medical, Groton, CT 06340, USA.
  • Inselman A; U.S. Food and Drug Administration, National Center for Toxicological Research, Division of Systems Biology, Jefferson, AR 72079, USA.
  • Hayes B; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
  • Casiraghi C; Department of Experimental Pharmacology and Translational Science, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.
  • Joseph D; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
  • Facchinetti F; Department of Experimental Pharmacology and Translational Science, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.
  • Salomone F; Department of Experimental Pharmacology and Translational Science, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.
  • Schmitt G; Pharma Research and Early Development, Roche Innovation Center Basel, Pharmaceutical Sciences, F. Hoffmann-La Roche, 4070 Basel, Switzerland.
  • Hui J; Bristol Myers Squibb, Nonclinical Research and Development, Summit, NJ 07901, USA.
  • Davis-Bruno K; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
  • Van Malderen K; Federal Agency for Medicines and Health Products (FAMHP), Department DG PRE authorization, 1210 Brussels, Belgium.
  • Morford L; Eli Lilly, Global Regulatory Affairs, Indianapolis, IN 46285, USA.
  • De Schaepdrijver L; Janssen R&D, Preclinical Sciences & Translational Safety, 2340 Beerse, Belgium.
  • Wiesner L; Federal Institute for Drugs and Medical Devices, Clinical Trials, 53175 Bonn, Germany.
  • Kourula S; Janssen R&D, Drug Metabolism & Pharmacokinetics, 2340 Beerse, Belgium.
  • Seo S; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
  • Laffan S; GlaxoSmithKline, Non-Clinical Safety, Collegeville, PA 19406, USA.
  • Urmaliya V; Janssen R&D, Discovery Sciences, 2340 Beerse, Belgium.
  • Chen C; Health and Environmental Sciences Institute, Washington, DC 20005, USA.
Dis Model Mech ; 15(4)2022 04 01.
Article em En | MEDLINE | ID: mdl-35466995
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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Displasia Broncopulmonar / Enterocolite Necrosante / Doenças do Recém-Nascido Tipo de estudo: Prognostic_studies Limite: Humans / Newborn Idioma: En Revista: Dis Model Mech Assunto da revista: MEDICINA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Displasia Broncopulmonar / Enterocolite Necrosante / Doenças do Recém-Nascido Tipo de estudo: Prognostic_studies Limite: Humans / Newborn Idioma: En Revista: Dis Model Mech Assunto da revista: MEDICINA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos