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Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.
Hey, Spencer Phillips; Feldman, William B; Jung, Emily H; D'Andrea, Elvira; Kesselheim, Aaron S.
Afiliação
  • Hey SP; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School
  • Feldman WB; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School
  • Jung EH; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School
  • D'Andrea E; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School
  • Kesselheim AS; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School
J Law Med Ethics ; 47(3): 381-387, 2019 09.
Article em En | MEDLINE | ID: mdl-31560631

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Biomarcadores / Guias como Assunto Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: J Law Med Ethics Assunto da revista: ENFERMAGEM / ETICA / JURISPRUDENCIA / MEDICINA / PESQUISA EM SERVICOS DE SAUDE Ano de publicação: 2019 Tipo de documento: Article País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Biomarcadores / Guias como Assunto Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: J Law Med Ethics Assunto da revista: ENFERMAGEM / ETICA / JURISPRUDENCIA / MEDICINA / PESQUISA EM SERVICOS DE SAUDE Ano de publicação: 2019 Tipo de documento: Article País de publicação: Reino Unido