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A review of the experience with pediatric written requests issued for oncology drug products.
Akalu, Alemayehu Y; Meng, Xi; Reaman, Gregory H; Ma, Lian; Yuan, Weishi; Ye, Jingjing.
Afiliación
  • Akalu AY; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Meng X; Department of Biostatistics, School of Public Health and Health Sciences, University of Massachusetts, Amherst, Massachusetts.
  • Reaman GH; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Ma L; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Yuan W; Division of Pharmacometrics (DPM), Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Ye J; Division of Biostatistics IX (DBIX), Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
Pediatr Blood Cancer ; 68(2): e28828, 2021 02.
Article en En | MEDLINE | ID: mdl-33245181
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas / Evaluación de Medicamentos / Neoplasias / Antineoplásicos Tipo de estudio: Prognostic_studies Límite: Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Pediatr Blood Cancer Asunto de la revista: HEMATOLOGIA / NEOPLASIAS / PEDIATRIA Año: 2021 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas / Evaluación de Medicamentos / Neoplasias / Antineoplásicos Tipo de estudio: Prognostic_studies Límite: Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Pediatr Blood Cancer Asunto de la revista: HEMATOLOGIA / NEOPLASIAS / PEDIATRIA Año: 2021 Tipo del documento: Article