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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.
Afiliação
  • 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 em En | MEDLINE | ID: mdl-34339865

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Confiabilidade dos Dados Tipo de estudo: Clinical_trials / Guideline Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Confiabilidade dos Dados Tipo de estudo: Clinical_trials / Guideline Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article