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Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
Agrawal, Sundeep; Arora, Shaily; Amiri-Kordestani, Laleh; de Claro, R Angelo; Fashoyin-Aje, Lola; Gormley, Nicole; Kim, Tamy; Lemery, Steven; Mehta, Gautam U; Scott, Emma C; Singh, Harpreet; Tang, Shenghui; Theoret, Marc R; Pazdur, Richard; Kluetz, Paul G; Beaver, Julia A.
Afiliación
  • Agrawal S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Arora S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Amiri-Kordestani L; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • de Claro RA; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Fashoyin-Aje L; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Gormley N; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Kim T; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
  • Lemery S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Mehta GU; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Scott EC; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Singh H; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Tang S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Theoret MR; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Beaver JA; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
JAMA Oncol ; 9(2): 266-272, 2023 02 01.
Article en En | MEDLINE | ID: mdl-36580315
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Texto completo: 1 Colección: 01-internacional Asunto principal: Productos Biológicos / Antineoplásicos Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: JAMA Oncol Año: 2023 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Asunto principal: Productos Biológicos / Antineoplásicos Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: JAMA Oncol Año: 2023 Tipo del documento: Article