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The use of real-world data/evidence in regulatory submissions.
Song, Fuyu; Zang, Chenxuan; Ma, Xinyi; Hu, Sifan; Sun, Qiqing; Chow, Shein-Chung; Sun, Hongqiang.
Afiliación
  • Song F; Center for Food and Drug Inspection, National Medical Products Administration, Beijing, China.
  • Zang C; Duke University School of Medicine, Durham, North Carolina, USA.
  • Ma X; Amherst College, Amherst, Massachusetts, USA.
  • Hu S; Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
  • Sun Q; Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
  • Chow SC; Duke University School of Medicine, Durham, North Carolina, USA.
  • Sun H; Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China. Electronic address: sunhq@bjmu.edu.cn.
Contemp Clin Trials ; 109: 106521, 2021 10.
Article en En | MEDLINE | ID: mdl-34339865
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Exactitud de los Datos Tipo de estudio: Clinical_trials / Guideline Límite: Humans País/Región como asunto: America do norte Idioma: En Año: 2021 Tipo del documento: Article
Texto completo
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XML
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Exactitud de los Datos Tipo de estudio: Clinical_trials / Guideline Límite: Humans País/Región como asunto: America do norte Idioma: En Año: 2021 Tipo del documento: Article