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FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.
Casey, Denise; Demko, Suzanne; Sinha, Arup; Mishra-Kalyani, Pallavi S; Shen, Yuan-Li; Khasar, Sachia; Goheer, M Anwar; Helms, Whitney S; Pan, Lili; Xu, Yuan; Fan, Jianghong; Leong, Ruby; Liu, Jiang; Yang, Yuching; Windsor, Katherine; Ou, Mei; Stephens, Olen; Oh, Byeongtaek; Reaman, Gregory H; Nair, Abhilasha; Shord, Stacy S; Bhatnagar, Vishal; Daniels, Selena R; Sickafuse, Sharon; Goldberg, Kirsten B; Theoret, Marc R; Pazdur, Richard; Singh, Harpreet.
Afiliación
  • Casey D; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.
  • Demko S; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.
  • Sinha A; Office of Biostatistics, FDA, Silver Spring, Maryland.
  • Mishra-Kalyani PS; Office of Biostatistics, FDA, Silver Spring, Maryland.
  • Shen YL; Office of Biostatistics, FDA, Silver Spring, Maryland.
  • Khasar S; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.
  • Goheer MA; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.
  • Helms WS; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.
  • Pan L; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Xu Y; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Fan J; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Leong R; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Liu J; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Yang Y; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Windsor K; Office of Pharmaceutical Quality, FDA, Silver Spring, Maryland.
  • Ou M; Office of Pharmaceutical Quality, FDA, Silver Spring, Maryland.
  • Stephens O; Office of Pharmaceutical Quality, FDA, Silver Spring, Maryland.
  • Oh B; Office of Pharmaceutical Quality, FDA, Silver Spring, Maryland.
  • Reaman GH; Oncology Center of Excellence, FDA, Silver Spring, Maryland.
  • Nair A; Oncology Center of Excellence, FDA, Silver Spring, Maryland.
  • Shord SS; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland.
  • Bhatnagar V; Oncology Center of Excellence, FDA, Silver Spring, Maryland.
  • Daniels SR; Division of Clinical Outcome Assessment, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
  • Sickafuse S; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.
  • Goldberg KB; Oncology Center of Excellence, FDA, Silver Spring, Maryland.
  • Theoret MR; Oncology Center of Excellence, FDA, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, FDA, Silver Spring, Maryland.
  • Singh H; Office of Oncologic Diseases, FDA, Silver Spring, Maryland. Bonnie.Singh@fda.hhs.gov.
Clin Cancer Res ; 27(15): 4142-4146, 2021 08 01.
Article en En | MEDLINE | ID: mdl-33712511
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Bencimidazoles / Aprobación de Drogas / Neurofibroma Plexiforme Tipo de estudio: Clinical_trials / Risk_factors_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Bencimidazoles / Aprobación de Drogas / Neurofibroma Plexiforme Tipo de estudio: Clinical_trials / Risk_factors_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article