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A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.
Raju, G K; Gurumurthi, Karthik; Domike, Reuben; Kazandjian, Dickran; Landgren, Ola; Blumenthal, Gideon M; Farrell, Ann; Pazdur, Richard; Woodcock, Janet.
Afiliação
  • Raju GK; Light Pharma, Inc., Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
  • Gurumurthi K; Light Pharma, Inc., Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
  • Domike R; Light Pharma, Inc., Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
  • Kazandjian D; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, National Cancer Institute, Silver Spring, Maryland, USA.
  • Landgren O; Memorial Sloan Kettering Cancer Center, New York, New York, USA.
  • Blumenthal GM; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, National Cancer Institute, Silver Spring, Maryland, USA.
  • Farrell A; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, National Cancer Institute, Silver Spring, Maryland, USA.
  • Pazdur R; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, National Cancer Institute, Silver Spring, Maryland, USA.
  • Woodcock J; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, National Cancer Institute, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 103(1): 67-76, 2018 Jan.
Article em En | MEDLINE | ID: mdl-28901535

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Medição de Risco / Mieloma Múltiplo Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Medição de Risco / Mieloma Múltiplo Idioma: En Ano de publicação: 2018 Tipo de documento: Article