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Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020.
Samuels, Sherbet; Park, Kyunghun; Bhatt-Mehta, Varsha; Sun, Haihao; Mulugeta, Yeruk; Yao, Lynne; Green, Dionna J; Burckart, Gilbert J.
Afiliación
  • Samuels S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Park K; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bhatt-Mehta V; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sun H; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Mulugeta Y; Office of New Drugs, Division of Pediatrics and Maternal Health, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yao L; Office of New Drugs, Division of Pediatrics and Maternal Health, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Green DJ; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
J Clin Pharmacol ; 63(3): 307-313, 2023 03.
Article en En | MEDLINE | ID: mdl-36150423
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Etiquetado de Medicamentos / Desarrollo de Medicamentos Límite: Adult / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: J Clin Pharmacol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Etiquetado de Medicamentos / Desarrollo de Medicamentos Límite: Adult / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: J Clin Pharmacol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido