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Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.
Green, Dionna J; Burnham, Janelle M; Schuette, Paul; Liu, Xiaomei I; Maas, Brian M; Yao, Lynne; McCune, Susan K; Chen, Joseph; van den Anker, John N; Burckart, Gilbert J.
Afiliação
  • Green DJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Burnham JM; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Schuette P; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Liu XI; Children's National Medical Center, Washington, DC, USA.
  • Maas BM; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
  • Yao L; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • McCune SK; Office of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, MD, USA.
  • Chen J; University of California San Diego, Skaggs School of Pharmacy, San Diego, CA, USA.
  • van den Anker JN; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
  • Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
J Clin Pharmacol ; 58(7): 885-890, 2018 07.
Article em En | MEDLINE | ID: mdl-29663424
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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Ensaios Clínicos como Assunto Tipo de estudo: Prognostic_studies Limite: Adult / Child / Humans País/Região como assunto: America do norte Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2018 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: United States Food and Drug Administration / Ensaios Clínicos como Assunto Tipo de estudo: Prognostic_studies Limite: Adult / Child / Humans País/Região como assunto: America do norte Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos